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

Model Number	WA69416M
Medical Device Problem Codes	Break (1069); Melted (1385); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide correction to the initial with information inadvertently left out (b5, d4, and g2).And to provide updates to fields (h3 and h4).The device was evaluated by olympus.It was confirm, that the insulating body between the jaw parts and the shaft insulation of the jaw insert was damaged, by an hf electric arc.And the ceramic axis is broke.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, it is likely, the suggested event occurred, due to improper handling, severe high frequency arcing caused by accidental contact with other surgical equipment or the distal jaws constantly touching, during high frequency application without tissue contact.Resulting, in a short circuit in the device.However, the root cause of the reported event could not be identified.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported, that the pin in the movable part (fulcrum part) is damaged.And some parts have fallen off (some of the recovered pieces are placed in a pouch and attached).
Additional Manufacturer Narrative
E1/establishment name: (b)(6) hospital added here due to character limitation in respective field.To date, the device has not been returned.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported during a therapeutic total hysterectomy the "hicura" bipolar hand instrument was used in combination with a non-olympus high-frequency device, and the forceps did not close when the handle was squeezed.There were burnt spots on the forceps insulation and some parts were chipped/melted.The body was thoroughly search, but no fragments were found, so the forceps were discontinued and replaced with similar equipment.Although the procedure took nearly two hours longer than scheduled, it was completed.The fallen pieces were not recovered.The size of the fallen pieces and the part (organ) from which they fell off were both unknown.There was no reported patient impact.

• Brand Name: JAWS INSERT "HICURA", 5 X 330, MARYLAND, BIPOLAR
• Common Device Name: HICURA HAND INSTRUMENTS
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18864687
• Report Number: 9610773-2024-00652
• Device Sequence Number: 15524554
• Product Code: GEI
• UDI-Device Identifier: 04042761080002
• UDI-Public: 04042761080002
• 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): Unknown
• 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): 05/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA69416M
• Device Lot Number: 23605-0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• 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: 02/15/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NON-OLYMPUS HIGH FREQUENCY DEVICE; WA69002M HANDLE ¿HICURA¿, SIZE M, BIPOLAR; WA69400M SHAFT ¿HICURA¿, 5 X 330, BIPOLAR
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female