MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12-30, ESG TURIS

Model Number WA22706S

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for physical evaluation.The definitive cause of the customer's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported during a cystoscopy and transurethral resection of the prostate (turp) using a hf-resection electrode (plasma loop) with a borrowed resectoscope, the first loop broke during the case and fell into the patient.They removed the first broken electrode.(this report).A second loop was opened and upon starting to use the second electrode, it broke as well and fell into the patient.The doctor was not able to remove this loop fragment (reported in related complaint with patient identifier (b)(6)).A third loop was opened, it partially broke, but did not fall into the patient (reported in related complaint with patient identifier (b)(6)).The user then pulled out their own resectoscope working element and opened a 4th loop.The procedure was then completed without any further difficulty.There was no other changes to the fluid, generator, or settings.The user could not verify if the borrowed working element was the exact same model cause as their resectoscope.The patient did not experience any adverse effects as a result of this occurrence and was discharged as planned.

Manufacturer Narrative

This report is being updated to provide investigation findings.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.Conclusion: based on the data presently available, it is concluded that excessive force in combination with anatomical or procedural complication during surgery contributed to the reported event.

Manufacturer Narrative

This report is being updated to provide additional investigation findings.Investigation analysis update: the patient received standard, continuous, high-flow bladder irrigation for up to 24 hours after the turp procedure.This bladder irrigation probably flushed any remaining fragment of the loop out of the bladder.There is no known problem related to the event after the patient's discharge.Moreover, even if a fragment remained in the bladder, it is unlikely to cause a serious injury afterwards.The returned first electrode that broke during the procedure and was retrieved shows a wire breakage where the loop has melted down to the fork insulation.This procedure can sometimes be very dynamic, especially if the plasma arc is maintained and the surgeon notices the damage to the loop belatedly.There are melting points on the ceramic insulation tubes as well as clear traces of heat development on the insulation tubes.The minor rust at the proximal end of the electrode was most likely caused by dried rinsing solution and is not related to the distal damage on the loop.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12-30, ESG TURIS
• Type of Device: HF-RESECTION ELECTRODE "PLASMALOOP"
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 11064888
• MDR Text Key: 227215108
• Report Number: 9610773-2020-00301
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761085356
• UDI-Public: 14042761085356
• Combination Product (y/n): N
• PMA/PMN Number: K171965
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2021

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: WA22706S
• Device Catalogue Number: WA22706S
• Device Lot Number: 1000061354
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 03/11/2021; 08/12/2021
• Supplement Dates FDA Received: 03/30/2021; 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 84