MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TROCAR TUBE "HIGH-FLOW", 4 MM, 2 STOPCOCKS, ROTATABLE; HW70951

Model Number	A70951A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that the distal end was bent.The issue occurred during reprocessing.There were no reports of patient harm.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updates fields: b5, g3, h2, h3, h4, h6 and h11.The device was returned to olympus for inspection and the reported failure was confirmed.Based on the results of the investigation, it is likely caused by a component failure of the trocar tube.The cause of the damage is likely deterioration over time.A definitive root cause could not be identified.The suggested event is detectable and preventable by handling device in accordance with the following ifu.4.2.1 general inspection ¿ check that the product has: - no dents, cracks, kinks, or deformations - no deep scratches preparation - no corrosion - no missing or loose parts ¿ check all markings on the product for clear visibility.Olympus will continue to monitor field performance for this device.

• Brand Name: TROCAR TUBE "HIGH-FLOW", 4 MM, 2 STOPCOCKS, ROTATABLE
• Common Device Name: HW70951
• 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: 21644461
• Report Number: 9610773-2025-02154
• Device Sequence Number: 7574167
• Product Code: HRX
• UDI-Device Identifier: 04042761010573
• UDI-Public: 04042761010573
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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: Health Professional
• Device Model Number: A70951A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 06/16/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown