MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "TRUEVIEW II", 4 MM, 70°, AUTOCLAVABLE; RIGID ARTHROSCOPE

Model Number	A70942A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the telescope had a bent scope.The issue occurred during a therapeutic procedure.There were no reports of patient harm.Although there was a slight delay, the intended procedure was able to be successfully completed using a similar device.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the results of evaluation and legal manufacturer's final investigation.From the results of evaluation, the following items were observed: - confirmed - bent outer tube.- scratches on distal edge.- optical fiber - no image.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, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to excessive force such as a fall, impact or similar stress.There are no countermeasures necessary for the suggested phenomenon because the associated risk is acceptable.The manufacturer will monitor the occurrence rate in the context of the utilized quality management system.If necessary, the manufacturer will take action in the future.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE "TRUEVIEW II", 4 MM, 70°, 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: 19807262
• Report Number: 9610773-2024-01783
• Device Sequence Number: 20919782
• Product Code: HRX
• UDI-Device Identifier: 04042761010559
• UDI-Public: 04042761010559
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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: A70942A
• Device Lot Number: 808376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2019
• 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 Age: 74 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White