MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°/16°, ESG TURIS

Model Number WA22702S

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2021

Event Type  Injury  

Manufacturer Narrative

The referenced device has not yet been returned.However, the investigation is ongoing.Therefore, the root cause of the reported malfunction cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

During the middle of a transurethral resection of a prostate procedure, the loop wire at the distal tip of the high frequency resection electrode broke off and fell into the patient's bladder.The operating room nurse further reported, there was a 15 minute delay as the loop fragments were retrieved from the patient using grasping forceps.The intended procedure was completed using a different electrode.The patient was inspected and no injury or no infection was reported.Additionally, no other devices were replaced, there was no sparking/arcing observed, there was no error codes observed, and no unexpected bleeding to the patient during the procedure.The generator settings when the reported phenomenon occurred was 200 saline cut / 120 saline coag.The electrode was inspected prior to use and no anomalies was observed.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation and device inspection.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation and device inspection, the phenomenon likely occurred due to wear and tear.Typical wire breakage was observed at the distal end of the electrode with wire ends melted into balls.The electrode contact at the proximal end shows no damage and no parts missing.The loop at the distal end of the electrode wears out during use and may break, burn, or melt.

Manufacturer Narrative

In response to an fda request, this report has been escalated to an adverse event.This supplemental report was submitted to provide correction to section b1, b2, h1 and h6.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°/16°, ESG TURIS
• Type of Device: HF-RESECTION ELECTRODE "PLASMALOOP"
• 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: 11271898
• MDR Text Key: 242737600
• Report Number: 9610773-2021-00064
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761085325
• UDI-Public: 14042761085325
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2022

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: WA22702S
• Device Catalogue Number: WA22702S
• Device Lot Number: 1000063322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 05/04/2021; 11/23/2022
• Supplement Dates FDA Received: 05/05/2021; 12/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2020
• 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: OLYMPUS GENERATOR: ESG-400, SN (B)(4).
• Patient Outcome(s): Other
• Patient Sex: Male