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

Model Number WA00014A

Device Problem Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2021

Event Type  malfunction  

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 Description

Olympus was informed that approx.10 minutes after the start of a therapeutic transurethral resection of the prostate (turp) procedure, the hf output reportedly became unstable.The loop electrode was then replaced, but the condition did not improve.The surgeon continued with the procedure but then a spark occurred at the base of the hf cable¿s l shaped connector.The surgeon, who was wearing two layers of gloves, felt a clear feeling of heat in his hands but only sustained a minor burn that did not require any treatment.The hf cable was replaced and the intended procedure was completed.There was no report about an adverse event or patient injury.

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for investigation/evaluation but to olympus medical systems corporation (omsc), japan (returned to omsc on 2021-08-25).The evaluation at omsc confirmed that the hf cable is broken near the angled connector.Furthermore, the inner wires near the straight connector were found to be broken.This type if damage is usually caused by age-related wear and tear in connection with a repeated tensile/bending load.The broken wires may then cause electric arcing when the hf generator is activated as reported by the customer.According to the article¿s lot number, the hf cable was manufactured in may 2018.It is therefore 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, BIPOLAR
• Type of Device: HF-CABLES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 12382082
• MDR Text Key: 274060385
• Report Number: 9610773-2021-00236
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• Combination Product (y/n): N
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

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
• Device Operator: Health Professional
• Device Model Number: WA00014A
• Device Catalogue Number: WA00014A
• Device Lot Number: 185W
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/19/2021
• Initial Date FDA Received: 08/30/2021
• Supplement Dates Manufacturer Received: 09/27/2021
• Supplement Dates FDA Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR