MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS INSERT "HICURA", 5 X 330, PRECISION, BIPOLAR; WA69424M

Model Number	WA69424M
Medical Device Problem Codes	Melted (1385); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 field: establishment name: due to limitation of text characters added here: national civil service mutual aid association (b)(6).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 during the procedure, while using the subject device, when outputting in a close state without contact with the metal of the monopolar machine, sparks flew and the tip of the subject device melted.The therapeutic uterine myomectomy procedure was completed after replacement with a similar olympus back up new device.The patient was under sedation with device outside the patient.The procedure was prolonged for only a few minutes for the replacement of the device.Per additional information malfunction occurred only during cutting output, did not occur during coag-output.There was no health hazard to the patient or the device user.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation and a device evaluation.Updated fields: d4, d8, d9, h2, h3, h4, h6 and h11.The device was returned to olympus for inspection and the reported failure was confirmed.During visual inspection revealed spark marks and melted insulation at the forceps tip.Based on the results of the investigation, the reportable issue was caused by a component failure of the jaws insert.The cause of the sparking and melting of the insulator at the forceps tip cannot be identified, but it could be that other equipment was output at a distance closer than 10 millimeters (mm), for example.A definitive root cause could not be identified.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: JAWS INSERT "HICURA", 5 X 330, PRECISION, BIPOLAR
• Common Device Name: WA69424M
• 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: 21858938
• Report Number: 9610773-2025-02711
• Device Sequence Number: 17320733
• Product Code: GEI
• UDI-Device Identifier: 04042761083669
• UDI-Public: 04042761083669
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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: WA69424M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2022
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELECTROCAUTERY KNIFE
• Patient Sex: Unknown