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

Model Number WA00014A

Device Problem Arcing (2583)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 07/07/2021

Event Type  Injury  

Manufacturer Narrative

The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome 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 during a therapeutic transurethral resection of the prostate (turp) and transurethral bladder tumor resection procedure, the hf-cable sparked and caused 2-3 degree burns on the tip of the 5th finger on the doctor's right hand.He had blisters with a diameter of about 1 cm that have healed now.The intended procedure was successfully completed with a similar cable.On the following day, the error log of the hf generator was checked, which showed error e006 ("no conductive fluid" or "hf instrument has not been properly connected") was present during the procedure.

Manufacturer Narrative

The suspect medical device was returned to the manufacturer for evaluation/investigation.During the investigation it was determined that the hf cable had already been repaired in the area of the connector, where the voltage flashover injuring the doctor¿s hand had occurred.However, such a repair is not intended and should not be carried out.Nevertheless, the reported issue is a known fault pattern which can be confirmed.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, BIPOLAR
• Type of Device: HF-CABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 12230829
• MDR Text Key: 263796666
• Report Number: 9610773-2021-00208
• 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: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA00014A
• Device Catalogue Number: WA00014A
• Device Lot Number: 154W-3678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 07/27/2021
• Supplement Dates Manufacturer Received: 09/10/2021
• Supplement Dates FDA Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS ESG-400 HF-GENERATOR; OLYMPUS WA22367A WORKING ELEMENT
• Patient Outcome(s): Other
• Patient Age: 77 YR