MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°, STERILE, SINGLE USE; HF-RESECTION ELECTRODES

Model Number WA22503D

Device Problems Break (1069); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2019

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 during an unspecified therapeutic resection procedure, the distal end of the hf resection electrode broke.It is unknown whether the electrode just broke or whether a fragment broke off and possibly fell into the patient.The intended procedure was successfully completed with a similar device and there was no report about an adverse event or patient injury.

Manufacturer Narrative

Device evaluation: the suspect medical device was not returned to the manufacturer for evaluation/investigation.Therefore, the manufacturer's evaluation was exclusively performed on the basis of the provided information.According to the available photo documentation, it could be confirmed that the loop wire at the distal end of the hf resection electrode is broken, the ends of the broken loop wire show molten material and the contact surface at the proximal end of the electrode shows signs (black spots) of arcing.The cause of the breakage of the loop wire is most likely an unintended contact of the electrode with another surgical instrument.However, mechanical overload or wear are also likely.The cause of the signs (black spots) at the contact surface is most likely that the hf resection electrode was inserted incorrectly into a working element.Residual moisture inside the ptfe body of the working element is another possibility.This lead to insufficient contacting between the electrode and the electrode connector inside the ptfe body, which in turn caused arcing.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 hf resection electrode 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 and retrained to correctly use the olympus medical devices.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°, STERILE, SINGLE USE
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 8526160
• MDR Text Key: 151869732
• Report Number: 9610773-2019-00061
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761068205
• UDI-Public: 14042761068205
• Combination Product (y/n): N
• PMA/PMN Number: K100275
• 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: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2022
• Device Model Number: WA22503D
• Device Catalogue Number: WA22503D
• Device Lot Number: 1000021050
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1