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

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
Additional Manufacturer Narrative
The referenced device was returned for evaluation and the customer¿s reported issue was confirmed.Deformation and scraping was identified on the distal tip of the device.No further information regarding the event was provided by the customer.A review of the (dhr) manufacturing and quality records for the affected lot number was reviewed without detecting any non-conformities or deviations regarding the described issue.The investigation is still in progress; however, if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The customer reported that the high-flow trocar tube has ¿deformation of the tip.¿ it was not specified when the event was found, however, the intended procedure was completed.No death or injury and no impact to patient or other has been reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Updated fields: h6 and h10.The d5, e1 "telephone number" and h8 fields were corrected based on information available at the time of the initial submission.Based on the results of the investigation, the tip of the device was damaged due to excessive force during user handling.Olympus will continue to monitor field performance for this device.

• Brand Name: TROCAR TUBE "HIGH-FLOW", 4 MM, 2 STOPCOCKS, ROTATABLE
• Common Device Name: RIGID TROCAR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 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: 17132113
• Report Number: 9610773-2023-01650
• Device Sequence Number: 6400207
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

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 Catalogue Number: A70951A
• Device Lot Number: 108W-0035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2010
• 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