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 Device Embedded In Tissue or Plaque (3165)

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 related 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 (this report).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 supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Though the subject device was not returned for evaluation, based on the legal manufacturer's investigation, it is likely that excessive force in combination with anatomical or procedural complication during surgery had contributed to the breakage.

Manufacturer Narrative

This report is being updated to provide an investigation update performed after the physical evaluation of the first loop used in the procedure that was broken off and retrieved (reported in mw 9610773 - 2020 - 00301).New information is reported in h6 and h10.Updated investigation findings: physical evaluation of the plasma loop broken off in the procedure and retrieved reveals: the electrode shows a wire break where the loop has melted down to the fork insulation.There are melting points on the ceramic insulation tubes as well as clear traces of heat development on the insulation tubes.It is not reported that fragments of the loop were recovered from the body.However, the origin of the crystalline residue on the electrode fork is unclear.Updated investigation analysis conclusion: during the use of the second electrode, this loop also broke and could not be removed.The third loop also broke, but no part fell into the patient.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.It is concluded excessive force in combination with anatomical or procedural complication during surgery has likely 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: 11064849
• MDR Text Key: 227362606
• Report Number: 9610773-2020-00300
• 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

• Date FDA Received: 12/23/2020
• 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
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 84