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

Model Number	MR-6LA
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the ureteroscope distal tip is bent.The issue occurred during preparation for use.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the evaluation found a bent outer tube, corrosion on the objective window, and debris under the eye piece window.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This supplemental report is to inform that upon further review, this is not a reportable malfunction.The initial medwatch reported that the distal tip is bent; however; per the legal manufacturer, this issue of a bent distal tip is not likely to cause or contribute to death or serious injury if the malfunction were to recur.

• 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: 18596486
• Report Number: 3011050570-2024-00029
• Device Sequence Number: 8124176
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

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
• Date Returned to Manufacturer: 01/22/2024
• 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: 01/11/2024
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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