MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OP TELESCOPE, 7°, 11 FR. X 220 MM, 7.5 FR. CHANNEL, ANGLED OCULAR; RIGID CYSTOSCOPE

Model Number	A37025A
Medical Device Problem Codes	Break (1069); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection.A root cause could not be identified.Based on the results of the investigation, it is likely that the malfunction was due to the body being crooked and crushed, the distal end being burned, and insertion tube failure.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was observed that during the device evaluation, the subject device exhibited a crooked and crushed body, a burned distal end, and insertion tube failure.There was no patient involvement.

• Brand Name: OP TELESCOPE, 7°, 11 FR. X 220 MM, 7.5 FR. CHANNEL, ANGLED OCULAR
• Common Device Name: RIGID CYSTOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22014141
• Report Number: 9610773-2025-03341
• Device Sequence Number: 20804307
• Product Code: FGA
• UDI-Device Identifier: 04042761023214
• UDI-Public: 04042761023214
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K853486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2025

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: A37025A
• Device Lot Number: 530161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2006
• 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