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

Model Number	A70951A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation as it was discarded by the customer.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Event or Problem Description
The customer reported to olympus.The distal end of the trocar broke off.The issue occurred during reprocessing.There were no reports of patient harm.There was no procedure or patient involvement.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation (h6/h10).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, the root cause could not be determined as the device was not returned for evaluation.Although the device was not returned, based on the information from the customer, it is likely the reported event occurred due to the use excessive force from improper handling (tool).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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17386022
• Report Number: 9610773-2023-01974
• Device Sequence Number: 20408730
• Product Code: HRX
• UDI-Device Identifier: 04042761010573
• UDI-Public: 04042761010573
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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
• Device Lot Number: 21302-0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2021
• 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