MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30°

Model Number WA22507D

Device Problem Material Disintegration (1177)

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

Event Date 05/08/2021

Event Type  Injury  

Manufacturer Narrative

The legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

During the middle of a myomectomy procedure, mechanical action was used in conjunction with energy for resection of the a patient fibroid.The procedure showed moderate bleeding, which made visualization difficult.To contain the bleeding, the high frequency electrode loop was being used in coagulation mode against the patient's tissue.However, due to bending and the difficulty of visualization, the electrode likely came into contact with the resectoscope's telescope or sheath; the loop broke with energy activation.No device fragment fell into the patient as the device fragment was vaporized by plasma recognition.The patient reacted by nervous reflex.The damaged electrode was removed and replaced with another electrode from the same lot.As a result, the surgery was delayed for an hour and a half.This issue did not result in a longer hospital stay and did not require additional patient treatment.The intended procedure was successfully completed and the patient is doing well.No death or serious injury was reported.A plasma resection kit was used with an electro-surgical generator and was set to saline cut 200/e2, saline coag 120/e2.There were no error codes observed.Prior to use, the electrode was inspected and no abnormalities were observed.No other devices were replaced.The subject electrode was disposed following the procedure.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer and to update the following sections: g3, g6, h2, h6 and h10.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The electrode shows a typical wire breakage with melting points at the wire ends.The remaining cutting wire presents a normal diameter.Since the wire ends melted into balls, it can be assumed that no wire fragment fell into the bladder.This statement is substantiated by the fact that the user could not find any wire fragments.Additionally, it was reported that the patient reacted by nervous reflex.Whether this is directly related to the breakage of the bipolar electrode or had another cause cannot be established.Based on the investigation, the probably cause of the reported issue is attributed to wear and tear.It should be noted that the loop at the distal end of the electrode wears out during use and may break, burn or melt.The legal manufacturer will continue to monitor the field performance of this device.

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 sections b1, b2, h1 and h6.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30°
• Type of Device: HF-RESECTION ELECTRODE, LOOP, 24 FR
• 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: 11930550
• MDR Text Key: 268697339
• Report Number: 9610773-2021-00153
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761068236
• UDI-Public: 14042761068236
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• 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

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22507D
• Device Catalogue Number: WA22507D
• Device Lot Number: 1000055951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2020
• 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 ESG-400, WB91051W S/N(B)(6).; OLYMPUS PLASMA RESECTION KIT FOR GYN
• Patient Outcome(s): Other