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

Model Number WA47706S

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/09/2022

Event Type  Injury  

Event Description

The customer reported to olympus during a hysteroscopy myomectomy (resection of a uterine fibroid) the loop broke.The loop broke completely off the electrode and was lost in the uterus for approximately 5-10 minutes.It was located and removed using a 5.5mm hysteroscope and graspers.A 2nd loop was used to complete the procedure.The customer reported "several broken loops previously." a request for additional information in progress.

Manufacturer Narrative

The suspect device has been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

The customer provided additional information: doctor confirmed the loop was retrieved in the case.The case finished as the doctor had hoped and the patient was planning to go home from the hospital same day.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the findings are as follows: the electrode loop of the "plasma loop" broke off in its entirety.In this respect, the damage was caused by forcible breakage which was preceded by deformation of the loop.The ends of the wires in the fork are repositioned in one direction.In addition, no burn marks are visible and there is contamination at the proximal end.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more than 1 year since the subject device was manufactured.Based on the results of the investigation, the reported event likely occurred due to an application of excessive force and improper handling.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TCRIS
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; JA 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 15555901
• MDR Text Key: 301330193
• Report Number: 9610773-2022-00461
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K171965
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2023

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: WA47706S
• Device Catalogue Number: WA47706S
• Device Lot Number: 1100363105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 10/06/2022
• Supplement Dates Manufacturer Received: 10/07/2022; 03/02/2023
• Supplement Dates FDA Received: 11/04/2022; 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2022
• 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: ESG-400; UNKNOWN ENDOSCOPE
• Patient Outcome(s): Other; Required Intervention