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

Model Number WA22302D

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

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

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

The suspect medical devices have 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 devices are returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

Olympus was informed that during a therapeutic transcervical resection in saline (tcris) procedure, the loop wire at the distal end of two hf resection electrodes from the same model broke off and fell inside the patient.Although the loop wires were not retrieved, an examination by x-ray showed no foreign objects inside the patient.The intended procedure was successfully completed with a third hf resection electrode and there was no report about an adverse event or patient injury.

Manufacturer Narrative

The suspect medical devices were not returned to the manufacturer for investigation but to olympus medical systems corporation (omsc), japan (returned to omsc on 2018-05-30).The investigation confirmed that the loop wire of two hf resection electrodes were broken and melted and the fork tubes were severely bent.Furthermore, the blue and yellow insulation of one of the suspect hf resection electrodes was charred.In addition, a third hf resection electrode was returned for investigation.The loop wire of this hf resection electrode was deformed, but not broken off.Also, the dilapan-s cervical dilator manufactured by medicam technology was returned as well which showed clearly visible loop-shaped marks on its surface.The ball-shaped end of the melted loop wires indicate that sparking took place due to unexpected contact with other metal parts (e.G.Sheath and/or telescope).Furthermore, the hf generator used for this procedure was manufactured by a third party manufacturer.This might also have been a contributing factor to cause excessive current running through the suspect medical devices.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 electrodes 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, 12°, STERILE, SINGLE USE
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 7568547
• MDR Text Key: 110042640
• Report Number: 9610773-2018-00053
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761051665
• UDI-Public: 14042761051665
• 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: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2022
• Device Model Number: WA22302D
• Device Catalogue Number: WA22302D
• Device Lot Number: 1000018113
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED ERBE VIO ELECTRICAL SCALPEL; UNSPECIFIED ERBE VIO ELECTRICAL SCALPEL