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.(reported in complaint with patient identifier (b)(6)).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 complaint with patient identifier (b)(6)).A third loop was opened, it partially broke, but did not fall into the patient (this report).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 results.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, olympus concludes that excessive force in combination with anatomical or procedural complication during surgery has contributed to the breakage.

Manufacturer Narrative

This report is being updated to provide additional investigation findings.Update based on more detailed information.Physical evaluation of the suspect device reveals: the electrode shows a broken wire on one side.There is a melting point at the ends of the broken wire as well as clear traces of heat development on the blue insulating tube.However, no parts of the loop are missing.Updated conclusion: based on the data presently available, we conclude that excessive force in combination with anatomical or procedural complication during surgery has contributed to the breakage.

• 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: 11064779
• MDR Text Key: 228043598
• Report Number: 9610773-2020-00299
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• 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: 03/22/2021; 08/12/2021
• Supplement Dates FDA Received: 04/05/2021; 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 84