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

Model Number WA22706S

Device Problem Break (1069)

Patient Problem Unspecified Kidney or Urinary Problem (4503)

Event Date 04/14/2022

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user¿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.This event has been reported by the importer on mdr# 2951238 ¿ 2022- 00436.

Event Description

The customer reports during a transurethral resection of a bladder neck contracture using a plasma loop with an esg400 generator, the plasma loop broke and tore the prostate.The loop was not completely detached.One side of the loop was still attached, only one side was broken off.No device fragment fell off into the patient.It is unknown if there were any procedural or anatomical challenges that could have contributed to the loop breaking.There was no treatment/intervention required to treat the prostate tear.The patient's current condition is reported as "patient tolerated procedure well and sent to post anesthesia care unit (pacu) then home." the generator settings being used during the procedure were 220 saline cut and 120 saline coagulation.The generator did not malfunction in any way.

Manufacturer Narrative

This report is being updated to provide investigation findings.New information is reported in h6 and h10.Since the product for this info complaint was not returned to olympus, our investigation is based solely on the information provided by the customer.The product was sold on 08 february 2022.Analysis: kindly note that the event description is plausible.According to the event description, the loop broke during a procedure however, there a no reports of missing parts.Also, there is no error message from the generator that was used.The selected generator setting corresponds to the specifications.Cause: according to our investigators, the cause of the reported issue is most likely due to wear and tear.Additional information: it should be mentioned that the tip at the distal end of the electrode wears out during use and may break, burn or melt.Risk analysis: the risk to patients, users, and/or third parties associated with the reported issue was evaluated as acceptable.In general, the customer is required to check the function of all devices used prior to a procedure.Additionally, according to the instructions for use (ifu), a suitable replacement device must be provided during an application.Clinical assessment a review of the new information was completed.The medical safety assessment remains unchanged, this is determined to be a serious injury as the broken piece of the loop likely tore the prostate.Dhr review: a manufacturing and quality control review was performed for device lot number.There is no non-conformity associated with this device with respect to the described issue.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TURIS
• Type of Device: ELECTRODES, ELECTROSURGICAL
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 14771971
• MDR Text Key: 294490549
• Report Number: 9610773-2022-00229
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761085356
• UDI-Public: 14042761085356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171965
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22706S
• Device Catalogue Number: WA22706S
• Device Lot Number: 1000087453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 06/22/2022
• Supplement Dates Manufacturer Received: 07/11/2022
• Supplement Dates FDA Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ESG400, SN: (B)(4).
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 76 KG