MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OP-TELESCOPE, 30°, 4 MM CHANNEL; OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE

Model Number	WA33036A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation, and the customer¿s allegation was confirmed.The evaluation found the following reportable issues: the light guide connector was broken.The following non-reportable malfunctions were found during the device evaluation: there was image failure due to the cover glass adhesion failing, the adhesion failed on the tip cover glass, and there were scratches on the gold plated side of the outer tube.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus that the op-telescope, 30°, 4 mm channel had damage to the mouthpiece of the treatment instrument.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, the root cause of the event could not be determined although it can be presumed that it was caused due excessive force.Olympus will continue to monitor field performance for this device.

• Brand Name: OP-TELESCOPE, 30°, 4 MM CHANNEL
• Common Device Name: OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18432613
• Report Number: 9610773-2024-00060
• Device Sequence Number: 7660512
• Product Code: FGA
• UDI-Device Identifier: 04042761051866
• UDI-Public: 04042761051866
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K853486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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: WA33036A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2023
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2010
• 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