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

Model Number	A22251C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/04/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
This supplemental report is being submitted to report the device evaluation results.The device was returned to service center for evaluation.A visual inspection was performed on the received device and noted that the axis that holds the roller in place was damaged.The roller is still in its original position; however, the wire that connects to left side of the axis is broken.The distal end was further inspected and noted the broken section has evidence of burn marks.The shaft was checked and there is no dents or external damages.Based on the evaluation, the broken left axis roller on the distal end is due to mishandling 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.¿.
Additional Manufacturer Narrative
Additional information received from the user facility states that the doctor was performing a transurethral resection of the prostate (turp) when the wire broke.The loop (ball) fell into the patient and they were able to retrieve it by flushing it out.No other equipment was replaced during procedure.The electrode cord inspected for damage.The generator settings were unknown.The wire did not at any point come into contact with any hard or metal object.No portion of the broken wire fell into the patient.

• Brand Name: HF-RESECTION ELECTRODE, ROLLER,
• Common Device Name: HF-RESECTION ELECTRODE, ROLLER
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 8851343
• Report Number: 9610773-2019-00098
• Device Sequence Number: 259873
• Product Code: GCP
• UDI-Device Identifier: 14042761036815
• UDI-Public: 14042761036815
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K903323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2019

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 07/06/2019
• Supplement Date Received by Manufacturer: 07/29/2019; 08/15/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 08/18/2019; 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: A22040T INNER SHEATH , A22027A OUTER SHEATH; ERBIE GENERATOR; WA2T430A TELESCOPE, WA22067A RESECTOSCOPE,