MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP; ELECTRODES, PROBES

Model Number WA22306D

Device Problems Break (1069); Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been returned for evaluation/investigation.Therefore, the root cause of the reported phenomenon could not be determined at this time.A review of the device history record by the oem (original equipment manufacturer) was performed for the affected lot or serial number and found no non-conformities or deviations related to the reported phenomenon.This report will be supplemented accordingly following investigations.

Event Description

A user facility reported, during a myomectomy procedure, the device electrode loop completely loosened and fell into the uterine cavity of the patient when tissue fragments were being removed after resection at the end of the procedure.The cavity was drained, together with the tissue, the loop was removed from the patient.The intended procedure was completed with no patient impact or harm reported.There was no user injury reported.It was noted that the way the user performed the procedure and nature of the operation being performed by the user (mechanical action to remove the fibroid in relation to the endometrium, and this was done a few times during surgery) as stated by the reporter, it generated deformities in the electrode.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.Based on the results of the investigation, the cause of the reported issue is attributed to use error as well as wrong handling.Per oem (original equipment manufacturer) : kindly note that the loop at the distal end of the electrode wears out during use and may break, burn or melt.Especially if the loop is repeatedly subjected to mechanical stress as described in the event description.Additional information: it should be noted that electrodes are designed to cut and coagulate tissues and not to move/push them away or anything similar.Curette a22261a, 24 - 28 fr., 12° and 30° are available for these purposes.Olympus will continue to monitor complaints for this device.

• Brand Name: HF-RESECTION ELECTRODE, LOOP
• Type of Device: ELECTRODES, PROBES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 11783173
• MDR Text Key: 250008512
• Report Number: 9610773-2021-00130
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761051689
• UDI-Public: 14042761051689
• Combination Product (y/n): N
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22306D
• Device Catalogue Number: WA22306D
• Device Lot Number: 1000060800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1