MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, ROLLER,

Model Number A22251C

Device Problem Break (1069)

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

Event Date 07/04/2019

Event Type  malfunction  

Manufacturer Narrative

The electrode was not returned to the service center for investigation.The cause of the reported event could not be determined at this time.However, based on similar reported complaints the most probable cause of the reported event can be attributed to operator's technique from excessive force being applied to the device or the loop wire may have come in unintended contact with a metallic object during the hf output which can lead to damage of the loop wire.The original equipment manufacturer (oem) performed a review of the manufacturing and quality control for the affected lot or serial number without showing any non-conformities or deviations regarding the described issue.To date, no additional information was obtained from the reporter.However, if additional information becomes available or if the device is returned at a time, this report will be supplemented accordingly.

Event Description

The service center was informed that during a therapeutic transurethral resection of the prostate (turp) procedure, the electrodes axis that was holding the roller ball blade broke.It is unknown if the roller ball fell into the patient.The intended procedure was completed with a different device.No other equipment was replaced during procedure.There was no patient injury reported.

Manufacturer Narrative

The device was returned to the service center for evaluation.A visual inspection performed was performed on the received device and noted that the axis that holds the roller in place was damaged.The roller is missing from the device and the wire that connects to the roller is missing as well.The distal end was further inspected and noted the right arm of the tip is bent upward with evidence of burn marks on the tips.The shaft was checked and there were no dents or external damages.According to the ifu, it states ¿hf resectoscopes emit large amounts of energy.As a result the distal end of the endoscopic equipment becomes hot.There is a risk of burns or thermal damage to surgical equipment (e.G., surgical drapes, plastic materials, etc.¿.

• Brand Name: HF-RESECTION ELECTRODE, ROLLER,
• Type of Device: HF-RESECTION ELECTRODE, ROLLER
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 8851771
• MDR Text Key: 198126964
• Report Number: 9610773-2019-00099
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 14042761036815
• UDI-Public: 14042761036815
• Combination Product (y/n): N
• PMA/PMN Number: K903323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22251C
• Device Catalogue Number: A22251C
• Device Lot Number: 1000032410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1