MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH SHAFT "HICURA", 5 X 250, MONOPOLAR; HICURA HAND INSTRUMENTS

Model Number	WA69300S
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the shaft "hicura", 5 x 250, monopolar had the tip spark.The issue was found during the therapeutic procedure that was completed with the same equipment.There were no reports of patient harm.Related patient identifiers are as follows: (b)(6).
Additional Manufacturer Narrative
To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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.The device was returned to olympus for inspection, and the customer's complaint was confirmed.The device evaluation confirmed that there were spark marks at the tip of the shaft.Based on the results of the investigation, the reported sparks can be attributed to user error and wrong handling.This failure mode is likely caused by the "softcoag" mode being set too high.Resulting, thermal stress caused the damage to the shaft insulation coating and also damage to the combined jaw insert.However, the definitive root cause was unable to be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: SHAFT "HICURA", 5 X 250, MONOPOLAR
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18177112
• Report Number: 9610773-2023-03348
• Device Sequence Number: 18115307
• Product Code: GEI
• UDI-Device Identifier: 04042761079129
• UDI-Public: 04042761079129
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

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: WA69300S
• Device Lot Number: 22801-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2023
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• 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: WA69001M.; WA69326S.
• Patient Sex: Unknown