MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TROCAR TUBE "HIGH-FLOW", 4 MM, 2 STOPCOCKS, ROTATABLE; ARTHROSCOPY SYSTEM

Model Number	A70951A
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 and the evaluation found that the tip of the tube is broken and the passage of the tube is limited by deformation.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 arthroscopy system exhibited the tip of the tube was broken.There were no reports of patient involvement.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: d5, e1, e2, e3, g2(user facility and health professional was selected on initial, please disregard as this is pae on estimation).Additional information added to field h3, h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 03 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the wear and repeated use over time led to the broken tip of the tube, whereas due to excessive force by the user the tube was deformed.However, a definite root cause could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: TROCAR TUBE "HIGH-FLOW", 4 MM, 2 STOPCOCKS, ROTATABLE
• Common Device Name: ARTHROSCOPY SYSTEM
• 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: 18993343
• Report Number: 9610773-2024-00889
• Device Sequence Number: 15354601
• Product Code: HRX
• UDI-Device Identifier: 04042761010573
• UDI-Public: 04042761010573
• Combination Product (Y/N): N
• Initial Reporter Country: MN
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

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: A70951A
• Device Lot Number: 21411-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2021
• 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
• Patient Sex: Unknown