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FM0558 Rev. 3 MediVision Care and Maintenance

FM0678-Rev. 2-Rigid-Endoscope-Restoration-Warranty

Frequently Asked Questions:

Q. What regulatory requirements are there for scope repair?

Unfortunately, The FDA does not regulate Scope repair unless it is part of a registered manufacturer’s facility. MediVision Scope repair is Regulated and audited by the FDA because we are a Manufacturer. We are compliant to the FDA Quality System Regulation, California Food and Drug Branch regulation and we are ISO 13485 Certified. We are not aware of any other repair company that can claim these strict compliance standards.

Q. What is your turnaround time?

The average turnaround time for a rigid scope repair is 2-3 Working days after approval for a standard repair and 5-7 days for a major scope repair. Some of our repair procedures and adhesives have lengthy process times and require several hours before final leak and quality control testing.

Q. Are there any specific brands or types of scopes that you cannot repair?

Less than 1% of the rigid scopes received are estimated as non-repairable. We have no real limitations in terms of brands or types of scopes. We repair all makes and models. If a scope is deemed non-repairable we will work with you to find a replacement.

Q. After the scope is repaired will be able to process (cleaning and sterilization) the scope as we did originally? Does MediVision ever use latex in repairs?

If the original manufacturer’s Directions for Use indicate the original product was compatible to a particular sterilization process:  YES, you will be able to process that scope in the same manner after the repair. We have qualified various sterilization methods through our design control process for new scopes and have applied the same methods and materials to our repair process. We DO NOT use any latex materials in any repairs. All materials meet USP Class VI requirements for medical grade use.

Q. Can we request a loaner?

Please email us with a loaner request. Because our average turnaround time is 3 days for most repairs we can service our customers well without providing a loaner. Loaners create additional Shipping cost in both directions and if the loaner is damaged then the customer is faced with an additional repair charge. This must be considered when you request a loaner.

Q. What is your warranty period on a rigid scope repair? What is covered?

MediVision Scope repair was the first scope repair company to offer the industry best – ONE YEAR on all rigid scope repairs as compared to the typical 90 days. The warranty covers repairs completed and protects the customer from fluid invasion due to seal failure during the warranty period. The warranty does not cover damage caused by misuse, abuse or mishandling. (For example, dropping of scope, shaver or laser or RF damage to tip, damage from flash sterilization, etc.).

Q. Can you repair autoclavable scopes?

We were one of the first companies to repair autoclavable scopes. We have processes for replacing the Sapphire metalized windows/Lenses and we can laser weld the eyepiece and any other metal joints. We routinely autoclave the scopes before they are sent out as part of our QC process.

Q. Can you replace sapphire objectives on Dyonics®or Stryker®scopes?

We can replace sapphire windows and negative lenses as well as sapphire metalized windows and negative lenses.

Q. Do you “repair” rod lenses or objective lens assemblies?

We do not repair damaged optical components – we replace them. Repairing optics is a not recommended and may effect the optical performance.

Q. The distal tip of my scope is scratched. Can you polish this?

We only polish the tip of the scope if it does not effect the integrity of the scope design.

Q. Our scopes seem fine but then fog after sterilization. What causes this?

The scopes are designed to be hermetically sealed, through misuse and damage or the sterilization process the scope seal may fail and the scope may fog.  We will test your scope seals and leak and pressure test your scope as part of the repair process.

Q. Can MediVision provide detailed reports and history reports on scopes that are sent in for repair?

We were the first company to provide a service data report with before and after data and images. Detailed service reports are returned with every rigid repair.