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

Model Number WA22306D

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

The electrode was not returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.The manufacturing site also performed a dhr review and found no related nonconformance or deviations at the time of product release.As a preventive measure against device breakage, the device instructions for use warns against bending the distal tip and states, ¿the hf-resection electrode is a precise mechanical and electrical device which is very sensitive to mechanical and electrical stress.¿ the instructions for use also warns, ¿the use of damaged equipment, equipment that does not function properly and/or equipment with illegible or missing markings may cause infection, toxic shock, electrical, mechanical and thermal injury and/or unintended nerve stimulation.¿ the instructions for use also have pre-procedure directions for inspecting both the device and its packaging for damage and deformation.

Event Description

Olympus was informed that during a therapeutic transurethral resection of the prostate (turp) procedure, the electrode¿s wire broke off and fell into the patient.The surgeon was unable to locate the device fragment.It was reported that surgeon was using the electrode to move the patient¿s tissue around when the breakage occurred.No x-ray was performed and no additional bleeding was observed.The generator settings were unknown.The intended procedure was completed with a similar device.There was no patient injury reported.Additionally, the loop was inspected prior to use with no anomalies found.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation results, correct the device lot number and additional information.The loop was returned to the service center for evaluation.A visual inspection was performed on the received loop and noted that the distal end of the loop wire was broken off.The broken piece was not returned for evaluation.The electrode was further inspected and noted that the insertion tube was bent right next to the stabilization tube.Additionally there is evidence of foreign material at the tip of the distal end.No functionality testing could be performed due to the broken loop wire.Based on the evaluation findings, the cause of the broken loop wire and bent shaft is due to excessive force which is attributed to mishandling.In addition, the original equipment manufacturer (oem) performed a review of the manufacturing and quality control records for the affected lot or serial number without showing any non-conformities or deviations regarding the described issue.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR.
• Type of Device: HF-RESECTION ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 8313581
• MDR Text Key: 137440064
• Report Number: 2951238-2019-00422
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761051689
• UDI-Public: 14042761051689
• Combination Product (y/n): N
• PMA/PMN Number: K100275
• 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: 10/29/2019

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: WA22306D
• Device Catalogue Number: WA22306D
• Device Lot Number: 1000015947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 10/07/2019
• Supplement Dates FDA Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1