MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "TRUEVIEW II", 2.7 MM, 30°, AUTOCLAVABLE; RIGID ARTHROSCOPE

Model Number	A70961A
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed that during the device evaluation, the rigid arthroscope exhibited a broken optical lens, bent outer tube, and non-olympus outer adapter.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device was returned and the evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Correction: b5 (describe event or problem) should be: it was observed that during the device inspection, the telescope exhibited broken optical lenses.There were no reports of patient involvement.Correction: h6 (component code) should only be for: 866 - lenses.H6 (medical device problem code) should only be for: 1069 - break.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over seven (7) years since the subject device was manufactured.Based on the investigation results, broken optical lenses, could not be identified.Presumably, the reported failure mode/identified defect(s) can be attributed to improper handling and application of excessive force, impact to the device like fall, shock or similar stress.However, a definitive root cause could not be established.Olympus will continue to monitor the field performance for this device.

• Brand Name: TELESCOPE "TRUEVIEW II", 2.7 MM, 30°, AUTOCLAVABLE
• Common Device Name: RIGID ARTHROSCOPE
• 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: 19983278
• Report Number: 9610773-2024-01966
• Device Sequence Number: 20853726
• Product Code: HRX
• UDI-Device Identifier: 04042761010634
• UDI-Public: 04042761010634
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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: A70961A
• Device Lot Number: 742085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2017
• 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