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

Model Number	A70951A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed that during the device evaluation, the distal end on the insertion tube of the trocar tube was deformed.There was no patient involvement.
Additional Manufacturer Narrative
An olympus field service engineer (fse) was dispatched to the user facility and confirmed the reported issue [deformed distal end of insertion tube].The subject device will not be sent back to olympus for further evaluation and repair.Based on the results of the investigation, olympus confirmed the event, however, 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.

• Brand Name: TROCAR TUBE "HIGH-FLOW", 4 MM, 2 STOPCOCKS, ROTATABLE
• Common Device Name: TROCAR TUBE
• 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: 24530818
• Report Number: 9610773-2026-01717
• Device Sequence Number: 8933645
• Product Code: HRX
• UDI-Device Identifier: 04042761010573
• UDI-Public: 04042761010573
• Combination Product (Y/N): N
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

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: 19XW-0048
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown