MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 4 MM, 70°, CONNECTOR FOR LIGHT GUIDE ON TOP, AUTOCLAVABLE; RIGID RHINOSCOPE

Model Number	WA96206A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was observed that during the device inspection, the light guide lens on the rigid rhinoscope exhibited misaligned glass and was damaged.There were no reports of patient involvement.
Additional Manufacturer Narrative
Correction is being made to previously submitted g3: date received, by manufacturer.Which, was not late.The correct date was 05/13/2024.
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, it is likely the following led to the malfunction: excessive force as a result of an impact or a fall on the distal end of the optics.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 4 MM, 70°, CONNECTOR FOR LIGHT GUIDE ON TOP, AUTOCLAVABLE
• Common Device Name: RIGID RHINOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19341078
• Report Number: 9610773-2024-01264
• Device Sequence Number: 13003352
• Product Code: EOB
• UDI-Device Identifier: 04042761070089
• UDI-Public: 04042761070089
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K944072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2024

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: Other
• Device Model Number: WA96206A
• Device Lot Number: 800077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 05/17/2024; 09/12/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 05/20/2024; 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EVIS EXERA III VIDEO SYSTEM CENTER - CV-190
• Patient Sex: Unknown