MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TROCAR TUBE "HIGHFLOW", 4 MM, 1 STOPCOCK, ROTATABLE; ARTHROSCOPE

Model Number	A70950A
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection.A root cause could not be identified.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was observed that during the device evaluation, the [product] exhibited [reportable event].There was no patient involvement.
Event or Problem Description
It was observed that during the device evaluation, the trocar exhibited sharp edges on the distal end.There was no patient involvement.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide correction to b5.Corrected fields: b5.

• Brand Name: TROCAR TUBE "HIGHFLOW", 4 MM, 1 STOPCOCK, ROTATABLE
• Common Device Name: 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 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22871065
• Report Number: 9610773-2025-05279
• Device Sequence Number: 9285626
• Product Code: HRX
• UDI-Device Identifier: 04042761010566
• UDI-Public: 04042761010566
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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: A70950A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2017
• 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