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

Catalog Number WA22301D

Device Problems Bent (1059); Improper or Incorrect Procedure or Method (2017); Device Or Device Fragments Location Unknown (2590)

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

Event Date 02/24/2015

Event Type  malfunction  

Event Description

Olympus was informed that during a therapeutic transurethral resection of the bladder tumor (turbt) procedure, the user facility staff noticed a broken off and missing loop wire at the distal end of the hf resection electrode.It is unk when exactly this damage occurred and whether a fragment/part fell inside the pt.However, no pieces were found during search, under endoscopic view and by x-ray.Furthermore, it was reported that the operating surgeon accidentally activated the high-frequency output of the electrosurgical generator while the suspect medical device was being withdrawn from the resectoscope and thus was still located inside the resection sheath.The intended procedure was subsequently completed by using another hf resection electrode and there was no report about an adverse event or pt injury.

Manufacturer Narrative

The suspect medical device was not returned to the mfr for eval/investigation but to olympus medical systems corp.(omsc), (b)(4).The eval/investigation found the hf resection electrode with melted loop wire.However, no fragments could fall inside the pt as the platin-iridium wire has completely melted down at both fork tubes and thus no parts are actually missing.The present failure mode is typical for an unintended contact with other metal parts, e.G.Surgical instruments.Therefore this incident was classified as use error and the case will be closed from olympus side with no further actions.However, the 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.Olympus submits this incident as a medical device report (mdr) in abundance of caution.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 2204 5; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 0669662955
• MDR Report Key: 4595170
• MDR Text Key: 5484058
• Report Number: 9610773-2015-00011
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: WA22301D
• Device Lot Number: 14192P01L001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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 UES-40S ELECTROSURGICAL GENERATOR; (SERIAL # (B)(4))