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

Catalog Number WA22507D

Device Problem Melted (1385)

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

Event Date 04/30/2015

Event Type  malfunction  

Event Description

Cross-reference to mfr report # 9610773-2015-00031 and 9610773-2015-00032.This is report 3 out of 3.Olympus was informed that during a therapeutic hysteroscopic myomectomy procedure, the loop wires of seven hf resection electrodes in total broke/melted (through) inside the patient.However, it was reported that no fragments/parts fell inside the patient as the platin-iridium wires were vaporized completely and thus no parts were actually missing.The intended procedure was subsequently completed using another hf resection electrode and there was no report about an adverse event or patient injury.

Manufacturer Narrative

The suspect medical devices were returned to the manufacturer for evaluation/investigation.The evaluation/investigation found 5 of the 6 hf resection electrodes (b)(4) (lot number 14191p02l001) with completely broken off and missing loop wires.Furthermore, the fork tubes of all 6 devices are heavily bent/deformed and twisted.Causal for this damage and the subsequent breakage of the platin-iridium wires is mechanical overload by the application of excessive force.Therefore this event/incident was attributed to abnormal use/off-label use and the case will be closed from olympus side with no further actions.However, the event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results and pro re nata trained again on the correct usage of the olympus medical devices.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30°, STERILE, SINGLE USE,
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, 2204 5; GM 22045
• Manufacturer (Section G): OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O.; telickova 457/29; prerov, 7512 4; EZ 75124
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg, 22045 ; GM 22045 ; 4066966
• MDR Report Key: 4902051
• MDR Text Key: 6067668
• Report Number: 9610773-2015-00033
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: WA22507D
• Device Lot Number: 14191P02L001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OLYMPUS PK SUPERPULSE ((B)(4))
• Patient Age: 50 YR
• Patient Weight: 75