MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24-28 FR., 0.2 WIRE, MEDIUM, 45° ANGLED; HF-RESECTION ELECTRODES

Model Number WA22332D

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 05/27/2016

Event Type  malfunction  

Manufacturer Narrative

The hf resection electrode 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.Note: this type of hf resection electrode is intended for use in endoscopic urological surgical procedures and not in gynecological procedures like tcrs.

Event Description

Olympus was informed that during a therapeutic transcervical resection (tcr) procedure, the loop wire at the distal end of the hf resection electrode broke off inside the patient and remained there, since it could not be located.The intended procedure was successfully completed with another hf resection electrode and there was no report about an adverse event or patient injury.The patient was informed about the incident and released from the hospital the same day.

Manufacturer Narrative

Device evaluation: the suspect medical device was returned to the manufacturer for evaluation/investigation.The evaluation/investigation confirmed that the hf resection electrode is damaged and broken.The loop wire at the distal end is completely broken off and missing.Furthermore, the electrode shaft and the fork tubes are bent.This was caused by bending of the electrode shaft, fork tubes and loop wire.As clearly stated as a warning note in the instructions for use, the user must never try to bend the distal end/tip of the hf resection electrode.The hf resection electrode is a precise mechanical and electrical device which is very sensitive to mechanical and electrical stress.The user apparently did not follow these instructions since the damage of the hf resection electrode and the breakage of the loop wire were caused by bending of the electrode shaft, fork tubes and loop wire.Therefore, this event/incident was attributed to use error.In addition, 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 related to function and safety.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 retrained to correctly use the olympus medical devices.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24-28 FR., 0.2 WIRE, MEDIUM, 45° ANGLED
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O.; telickova 457/29; prerov, 75124 ; EZ 75124
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg, 22045 ; GM 22045 ; 40 66966
• MDR Report Key: 5722114
• MDR Text Key: 47324335
• Report Number: 9610773-2016-00024
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: WA22332D
• Device Catalogue Number: WA22332D
• Device Lot Number: 15219P01L001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2016
• Initial Date FDA Received: 06/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2015
• 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
• Patient Age: 61 YR