MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS INSERT "HICURA", 5 X 330, MARYLAND, BIPOLAR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	WA69416M
Medical Device Problem Codes	Break (1069); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1:(b)(6).The subject device was returned to an olympus repair center for evaluation and the customer¿s reported issue of the insulation at the tip of the forceps being damaged was confirmed.The device evaluation found; there were spark marks on the tip of the forceps.The cause of the issue was due to another device coming into contact with the part of the forceps that had spark marks during use.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Event or Problem Description
The customer reported to olympus, the jaws insert "hicura", 5 x 330, maryland, bipolar had the insulation at the tip of the forceps damaged.The issue was found during an unknown therapeutic procedure.There were no reports of patient harm.Evidence of sparking was found during the device evaluation.
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 of the event was unable to be identified.The present failure mode likely occurred due to improper handling.Severe high frequency (hf) arcing was caused by unintentional contact with other surgical equipment or the distal jaw parts were constantly touching during hf application without tissue contact, which led to a short circuit in the device.Olympus will continue to monitor field performance for this device.

• Brand Name: JAWS INSERT "HICURA", 5 X 330, MARYLAND, BIPOLAR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 18150407
• Report Number: 9610773-2023-03322
• Device Sequence Number: 14853551
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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 Lot Number: 23102-0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2023
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• 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: WA69002M.; WA69400M.
• Patient Sex: Unknown