MAUDE Adverse Event Report: GYRUS ACMI, INC URETEROSCOPE, 43CM

Model Number MR-6LA

Device Problems No Display/Image (1183); Poor Quality Image (1408)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.Initial evaluation determined that the device exhibited a cloudy image.The object window was found to have a chipped cover glass.The device was placed for repair.The device was sent out to olympus bartlett site service for further evaluation.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the device ureteroscope exhibited foggy, dark poor image.The issue occurred during preparation for use.There was no patient involvement in this report, no user harm or injury was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the review of the device history records (dhr).The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The device was evaluated by repair department and per evaluation, the customer reported issue of "poor/cloudy image" was confirmed.The evaluation found a chipped cover glass and minor scratches on objective frame a definitive root cause could not be determined however, the most probable cause of the issue was likely attributed to mishandling.Olympus will continue to monitor complaints for this device.

• Brand Name: URETEROSCOPE, 43CM
• Type of Device: URETEROSCOPE,
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10125890
• MDR Text Key: 209394512
• Report Number: 1519132-2020-00012
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K052044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR-6LA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1