MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, MONOPOLAR; ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE

Model Number	A0358
Medical Device Problem Codes	Break (1069); Electrical Shorting (2926)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer initially reported to olympus that when cutting the gallbladder of the patient during a laparoscopic cholecystectomy, an electric knife was used to perform electrocoagulation for hemostasis, and a sudden electrical conductivity at the electrocoagulation wire handle led to the surgeon's glove breakage, causing a burn of approximately 0.5x0.3 mm on the operator's right thumb.There was no patient injury reported.Olympus then received further information clarifying that the high-frequency cable (a0358) was damaged, and the surgeon touched the damaged area with their hands during use, resulting in burns.There was no malfunction of the esg-400 that was also used in the procedure.The customer further clarified that the surgeon sustained a third degree burn with a small area of 2x5 mm treated with cold application.There were no other symptoms or complications.The surgeon currently does not report any discomfort.
Additional Manufacturer Narrative
The suspect device was returned to olympus for evaluation.It has been more than 3 years since the device was manufactured.The cable connector at the end of the device was broken and has been repaired.The damaged patch part was damaged again and exposed the internal copper wire, and there was current leakage of the damaged part.The following possible causes were noted: 1.According to the lot number, the time of use was more than 3 years; according to the corresponding instructions, the cable life is about 200 times.2.In addition, according to the frequency of use, operating habits, storage and cleaning/disinfecting/sterilizing methods and other reasons, the cable has risk of wear and shortened life.3.The user should check the cable and plug before use to see if there are any abnormalities on the surface.Damaged cables are strictly prohibited to use.Cables must be replaced and cannot be repaired.4.It was found that the insulation cover of the cable was damaged and repaired, and current leakage occurred when the cable was damaged again, which was not a quality problem.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 device evaluation and the legal manufacturer's final investigation.During the subsequent examination it was found that the cable appeared to be damaged and was then provisionally repaired.The cable continued to be used in this condition, which then led to the user's burn at the "repaired" point.Dhr-review a manufacturing and quality control review was performed for the affected serial number without showing any non-conformities or deviations regarding the described issue.The dhr review showed, that the device was manufactured according to valid instructions and met all of its specifications.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-CABLE, MONOPOLAR
• Common Device Name: ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE
• 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: 18219819
• Report Number: 9610773-2023-03400
• Device Sequence Number: 6721491
• Product Code: HET
• UDI-Device Identifier: 04042761001557
• UDI-Public: 04042761001557
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K944200
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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: A0358
• Device Lot Number: 009003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2023
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2020
• 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: ESG-400 / (B)(6)
• Patient Sex: Unknown