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

Model Number	WA69416M
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An olympus representative reported to olympus on behalf of the customer that sparks flew from the tip of the jaws insert "hicura", 5 x 330, maryland, bipolar during a laparoscopic hysterectomy.The device was used with a non-olympus electrosurgical unit with a 30 watts setting.The use of the device was discontinued.The procedure was completed.There was no harm or user injury reported due to the event.Upon inspection and testing of the returned device, it was observed that the insulation and ceramic pin were damaged.This report is being submitted for the event found during evaluation.
Additional Manufacturer Narrative
The suspect device was returned to olympus for evaluation, and the reported failure could be reproduced.Visual inspection revealed damage to the tip insulator and the ceramic pin.It was suspected that the damage was caused by the sparks generated by dielectric breakdown at the tip of the forceps, such as when other equipment touched it.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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.It is likely the reported damage was caused by a current flashover/short circuit from improper handling.There was either unintentional contact with other equipment or the distal jaws were continuously touching without contact to tissue during application.Olympus will continue to monitor field performance for this device.

• Brand Name: JAWS INSERT "HICURA", 5 X 330, MARYLAND, BIPOLAR
• Common Device Name: DISSECTION FORCEPS
• 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: 16865711
• Report Number: 9610773-2023-01210
• Device Sequence Number: 5460643
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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: WA69416M
• Device Catalogue Number: WA69416M
• Device Lot Number: 224020009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2022
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONMED SYSTEM 2450.
• Patient Sex: Female