MAUDE Adverse Event Report: GYRUS ACMI, INC. URETEROSCOPE, 43CM; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	MR-6LA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the ureteroscope was found to have a blurry image during device reprocessing following a therapeutic procedure.Inspection and testing of the returned device found distal tip damage.There was no patient involvement.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation of blurry image was confirmed.The device evaluation found damage to the distal tip.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.The device was manufactured in august 2008, but the specific date was unknown.It has been over 15 years since the subject device was manufactured.Based on the device inspection findings and the incident information provided , the damage which occurred was most likely due to user mishandling during device reprocessing.The issue is addressed in the device instructions for use: "study this manual and other labeling thoroughly for safe handling and storage.Misuse of instruments can cause injury to the patient and could have an adverse effect on the procedure being performed.Do not drop instruments or allow them to be struck by other objects"; "prior to use, examine each electrode and its insulation for damage; do not use if damaged." olympus will continue to monitor the field performance of this device.

• Brand Name: URETEROSCOPE, 43CM
• Common Device Name: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17034883
• Report Number: 3003790304-2023-00213
• Device Sequence Number: 20560148
• Product Code: FGB
• UDI-Device Identifier: 00821925006232
• UDI-Public: 00821925006232
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K052044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MR-6LA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown