MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, MONOPOLAR; HF-CABLES

Model Number	A0358
Medical Device Problem Codes	Sparking (2595); Output Problem (3005); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Event or Problem Description
Olympus was informed that during an unspecified therapeutic laparoscopic surgery, the area near the connection between the hf-cable and the hf-electrode popped and a spark occurred.Before this happened the surgeon had felt the handle of the hf-electrode to be hot and the output performance of the electrode to be weaker than normal.The surgeon then replaced both the hf electrode and the hf-cable.The intended procedure was completed and there was no report about an adverse event or patient injury.
Additional Manufacturer Narrative
Additional information: h4 - device manufacturer date.Device evaluation: the suspect medical device was not returned to the manufacturer for evaluation/investigation but to olympus medical system corporation (omsc), japan (returned to omsc on 2022-08-18).During the evaluation at omsc the hf-cable was found to be broken/separated on the instrument connector side.The reported issue is a known fault pattern.Age-related wear and tear in connection with a repeated tensile/bending load most likely caused single or all wires inside the cable to break.When the hf generator is activated, this can result in a voltage flashover in the damaged area.According to the article¿s lot number, the hf cable was manufactured in 2015.It therefore must be assumed that the hf cable was used longer than the 12 months the cable is designed for.Thus, this event/incident can most likely be attributed to age-related wear and tear in connection with improper handling by the customer and thus to use error.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the hf cable without showing any abnormalities.The case will be closed on olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: HF-CABLE, MONOPOLAR
• Common Device Name: HF-CABLES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): BOWA-ELECTRONIC GMBH & CO KG; heinrich-hertz-strasse 4¿10; gomaringen
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 15292496
• Report Number: 9610773-2022-00346
• Device Sequence Number: 12554363
• Product Code: GCJ
• UDI-Device Identifier: 04042761001557
• UDI-Public: 04042761001557
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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 Catalogue Number: A0358
• Device Lot Number: 505619
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2015
• 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: OLYMPUS ESG-400 HF-GENERATOR (WB91051J).; OLYMPUS HF-ELECTRODE, HOOK, 5 X 330 MM (A6282).
• Patient Sex: Unknown