MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS INSERT "HICURA", 5 X 330, JOHANN, BIPOLAR; JAWS INSERT, BIPOLAR FORCEPS

Model Number	WA69410M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The referenced device has been disposed of by the user facility and the lot number is unknown.As part of the investigation, olympus followed up with the customer to obtain additional information regarding the reported event, but no further information was provided.The investigation is still ongoing; therefore, the root cause cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
Olympus (oj) was informed by the biomedical engineer at the user facility, during a laparoscopic hysterectomy when the tissue was grasped with the customer hicura, johann bipolar jaws insert, the tip broke and fell off.After removing the fallen part outside the body, the forceps was replaced with a replacement forceps from another company.The procedure was completed.No death, injury or impact was reported to olympus.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The d8 and e1 telephone number" fields were corrected based on information available at the initial report submission.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely that the fracture of the distal end was due to wear in the form of material fatigue.A definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: JAWS INSERT "HICURA", 5 X 330, JOHANN, BIPOLAR
• Common Device Name: JAWS INSERT, BIPOLAR FORCEPS
• 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: 16364498
• Report Number: 9610773-2023-00487
• Device Sequence Number: 12449731
• Product Code: GEI
• UDI-Device Identifier: 04042761079976
• UDI-Public: 04042761079976
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023

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: WA69410M
• Device Catalogue Number: WA69410M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2023
• Supplement Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female