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

Model Number WA00014A

Device Problems Break (1069); Arcing (2583); Sparking (2595)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 06/02/2022

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.30 minutes into a therapeutic transurethral resection of the prostate (turp) procedure, the esg-400 hf-generator issued an "insufficient conductivity" error message.The error was cleared and the procedure continued normally.A short time afterwards there was a bang and a spark / flash from where the hf able connected to the working element of the resectoscope.At this time the surgeon also received a shock through his hand, and possibly also a very small burn, which, however, did not require any medical treatment.Upon inspection of the instrument the hf cable had broken off from one of the working element connectors.The surgeon's glove also had a small charring mark and an approx.1cm split at the same point.The surgeon changed his gloves and used another hf cable to complete the intended procedure with no further issues.There was no report about an adverse event or patient injury.

Manufacturer Narrative

The suspect medical device was returned to the manufacturer for investigation.The investigation confirmed that the hf-cable had broken off from one of the working element connectors and that the wires at the other side of the cable were also broken.In the course of time, one or more wires inside the cable can break due to permanent bending/tensile stress, as well as wear and tear.When activating the generator, a voltage flashover at the damaged area might occur.This very likely causes a spark and the separation of the plug.Since the cable was manufactured in december 2016, the cause for the damage in the case at hand is most likely improper handling in combination with wear and tear as well as end-of life problem.Therefore, this event/incident was attributed to use error.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the bipolar hf-cable without showing any abnormalities.The case will be closed from olympus side with no further actions, but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, 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
• Manufacturer (Section G): MED CONTACT GMBH; kornbühlstr. 100-102; salmendingen
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 14651804
• MDR Text Key: 302001632
• Report Number: 9610773-2022-00212
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• 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: 16ZW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: OLYMPUS ESG-400 HF-GENERATOR (WB91051W); OLYMPUS WORKING ELEMENT (WA22367A); UNSPECIFIED OLYMPUS PLASMA RESECTOSCOPE
• Patient Sex: Male