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

Model Number A22201C

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 03/22/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported event could not be determined, however, based on similar reported complaints the most probable cause are as follows: the electrode loops are used to manipulate the surrounding tissue which can cause the loop wire to bend/break, electrical output settings on the electrosurgical generator are too high, and/or the loop wire comes in contact with metal during activation.If additional information becomes available or if the device is returned to olympus for evaluation at a later time, this report will be supplemented accordingly.

Event Description

Olympus was informed that the loop broke off the device and fell into the patient during a transurethral resection of a prostate tumor (turpt) procedure.The device fragment was retrieved from the patient with no issues.The intended procedure was completed using similar device.No patient injury was reported.The device will be returned to olympus for evaluation.

Manufacturer Narrative

The device was returned for evaluation.A visual inspection of the device noted the loop at the distal end was broken off and missing.The loop wire was not returned with the device.A microscope inspection was performed and revealed charring deposits at the tip of both yellow colored resection posts.There are small portions of the loop wire that remained and appeared to be melted which is an indication of thermal damage.Based on evaluation results and similar reported complaints, the most probable cause of the reported event could be due to the loop wire coming in contact with metal material during hf output which can attribute to melting and burning of the loop wire.

Manufacturer Narrative

The oem performed an evaluation for the reported lot number of the model a22201c hf resection electrode that was used and based on the oem¿s investigation it has been determined that the loop wires of the affected electrodes became damaged during production due to some irregularities in the manufacturing equipment.As a result, a field safety corrective action has been initiated to prevent potential risk to patient health.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR
• Type of Device: HF RESECTION ELECTRODE LOOP
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6458425
• MDR Text Key: 71838885
• Report Number: 2951238-2017-00219
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK903323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: A22201C
• Device Catalogue Number: A22201C
• Device Lot Number: P16Y0003
• Other Device ID Number: 14042761036648
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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