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

Model Number A22201C

Device Problem Break (1069)

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

Event Date 04/22/2019

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device has not been returned to the manufacturer for evaluation/investigation.A device history record (dhr) was performed and no non conformances were noted.The issues connected with cracking of tungsten wire electrodes are being further investigated.However, the exact cause of the user's experience and the reported phenomenon could not be determined at this time.If the suspect medical device is returned for evaluation/investigation and/or additional significant information becomes available, this report will be updated.

Event Description

The service center was informed that during a transurethral resection of bladder tumor (turbt) procedure, while the surgeon was resecting tissue it was noted that the loop was no longer attached to the tip of the 24fr resection loop.The surgeon and staff searched for the piece of loop through the cystoscope, in the specimen, and in the suction screen.After an extensive search the surgeon and staff was still were unable to find the piece of loop.No x-ray was performed as the surgeon felt the loop fragment would not be visible do to the size.The operating room supervisor verified no x-ray was required post- procedure due to the size of the object.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation results.Please the updates in sections: d10, g4, g7, h2, h3, h6 and h10.The reference device was returned to service center for a evaluation.Service center confirmed the loop is missing and not returned.A visual inspection was performed on the distal end under a microscope and revealed charring deposits at the tips, and that where the small portions of the loop wires left appeared to be melted.Also, one of the yellow insulation has an impression as a pressure mark.The stabilizing tube appeared to be slightly bent.However, the blue insulation shaft is straight, and its proximal end has no physical damage.Since the electrode loop was damaged, the device was not checked for functionality.Based on the investigation findings and similar reported event, the electrode has thermal damage.This event could have happened if the user applied too much pressure with the distal end to the tissue during use which led to the premature melting of the loop.Also, per ifu, this electrode model is not compatible for vaporization, only use for coagulation and cutting application purposes, therefore, incorrect application could have caused the reported issue.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR.
• Type of Device: RESECTION ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 8639049
• MDR Text Key: 146076755
• Report Number: 2951238-2019-00872
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 14042761036648
• UDI-Public: 14042761036648
• Combination Product (y/n): N
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/09/2019

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 Model Number: A22201C
• Device Catalogue Number: A22201C
• Device Lot Number: 16120P03L001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/23/2019
• Supplement Dates Manufacturer Received: 07/12/2019
• Supplement Dates FDA Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1