MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, BIPOLAR; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number WA00014A

Device Problems Break (1069); Failure to Conduct (1114); Arcing (2583); Sparking (2595)

Patient Problems Burn(s) (1757); Blister (4537)

Event Date 02/08/2023

Event Type  malfunction  

Event Description

A user facility reported to olympus that while performing plasma cutting with the hf-cable, bipolar, a spark came out of the cable.The resulting heat that was released melted the surgeons surgical glove and caused a slight burn with a blister.It was noted there was a slight delay during the lead exchange.There was no patient involvement.No other devices were replaced.

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer confirmed the procedure was a therapeutic (rtup)transurethral resection of the prostate and the procedure was prolonged 40 minutes.The procedure did not need to be cancelled and the condition of the patient was not impacted by the failure.The reported problem did not affect the diagnostic or therapeutic outcome of the procedure and no medical intervention (i.E., treatment outside the scope of the procedure) required because of the reported problem.No other devices were connected to the subject device when the failure occurred.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the cause of the phenomenon is likely due to the handling of the user.However, a specific root cause could not be identified.The event can be prevented by following the instructions for use which state: "the service life of hf cables is restricted to one year.Furthermore, the cable must be inspected before and after each use and reprocessing cycle.This can be done by slightly pulling the plug to identify if wires inside the cable are pre-damaged (a force with 20 n at most shall be used when pulling the plug).When the cable remains rigid and does not bend, this area of the cable is very likely faultless.Additionally, the cable shall be wound up with a diameter of less than 10 cm.When removing the cable, the plug shall be pulled and not the cable." olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event.Upon evaluation of the returned device, it was noted that the device was not in its original packaging.It was found that the right angle plug for the working element was detached from the cable.The detached portion was examined under a microscope and severely burnt cable was found as char marks were present.The cable insulation of the straight plug for the working element was detached from the plug.The condition of the lug housing had no signs of cracks or deformities.The male plug for the electrosurgical generator had signs of normal wear on the plug.Further functional tests were unable to be performed as the right angle plug for the working element was damaged and detached.The instructions for use contain the following warnings and cautions: "do not use the hf cable after 12 months of use." "dispose of the hf cable after 12 months." "accidentally disconnecting the hf cable can cause sparkover leading to electrical injury, thermal injury or unintended nerve stimulation." "connecting the hf cable to the wrong socket of the electrosurgical generator can damage the hf cable and the electrosurgical generator." "do not pull on the cable to disconnect the plug.Always pull on the plug to avoid arcing." it was confirmed that the angle plug was damaged and detached and could likely be attributed to wear and tear.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

• Brand Name: HF-CABLE, BIPOLAR
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• 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: 16562379
• MDR Text Key: 311712017
• Report Number: 9610773-2023-00776
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• 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: 16XW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2016
• 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