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

Model Number	MR-6LA
Medical Device Problem Codes	Break (1069); No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the ureteroscope distal tip was damaged and/or broken with a sharp edge, could not see the picture.There were no reports of patient harm or impact associated with this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer investigation results.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation and the information provided, the reported complaint of the image not being visible was confirmed.The cloudy image observed was likely due to debris under e/p window, which could be attributed to possible user mishandling.However, a definitive root cause could not be determined.The subject event can be detected and prevented by implementing in accordance with the below instructions for use (ifu): "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." (page 4); "pay close attention to the care, cleaning, disinfection, and sterilization instructions in this manual.Any deviation can cause damage." (page5) olympus will continue to monitor field for this device.

• Brand Name: URETEROSCOPE, 43CM
• Common Device Name: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20233737
• Report Number: 3011050570-2024-00376
• Device Sequence Number: 8089424
• Product Code: FGB
• UDI-Device Identifier: 00821925006232
• UDI-Public: 00821925006232
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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