MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30°, STERILE, SINGLE USE; HF-RESECTION ELECTRODES

Model Number WA22306D

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)

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

Event Date 05/25/2018

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 a therapeutic transurethral coagulation (tuc) procedure, the loop wire at the distal end of the hf resection electrode broke off and fell inside the patient.The loop wire was reportedly not retrieved but an examination by x-ray showed no foreign objects inside the patient.It was suspected that the fragment has been flushed out from the patient with irrigation fluid.The intended procedure was successfully completed with another hf resection electrode and 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 but to olympus medical systems corporation (omsc), japan (returned to omsc on 2018-06-06).The investigation confirmed that the hf resection electrode is damaged.The loop wire at the distal end has split and the remaining wire ends as well as the fork tubes are bent.However, no fragments fell inside the patient, since the platin-iridium wire has melted through and thus no parts are actually missing.The present failure mode is consistent with an unintended contact with other metal parts, e.G.Surgical instruments, while the high-frequency output was activated.Furthermore, the bent wire ends and fork tubes were caused by the application of excessive force.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, MEDIUM, 30°, STERILE, SINGLE USE
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 7586048
• MDR Text Key: 110579960
• Report Number: 9610773-2018-00054
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761051689
• UDI-Public: 14042761051689
• 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: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2022
• Device Model Number: WA22306D
• Device Catalogue Number: WA22306D
• Device Lot Number: 1000017760
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1