MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number WA22503D

Device Problem Material Deformation (2976)

Patient Problems Tachycardia (2095); Hyperextension (4523)

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if additional information is provided by the user facility.

Event Description

The customer reported to olympus, during an electric arc resection under general anesthesia, a cystoscopy and later a ureteroscopy was performed with a rigid endoscope.The resection in bladder was completed using a single use bipolar loop.Reportedly the loop was deformed and the electric current diffused into the patient and shocked the patient and there no more vision on the optics.This caused the patient to startle with hypertension of 180 systole for 15 minutes and tachycardia -115 bpm.There was no medical intervention required as a result of the electric shock.It was reported that there were no patient sequelae at the moment and patient was still waking up during the call.There is no report that a life-threatening event occurred, that the malfunction caused or contributed to a permanent impairment in the patient.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The device was evaluated where the users complaint was confirmed.The distal end of the electrode was deformed and the loop was burnt.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 investigation, it is likely improper handling/excessive force by the user caused the event.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18502754
• MDR Text Key: 333213396
• Report Number: 9610773-2024-00149
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761068205
• UDI-Public: 14042761068205
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22503D
• Device Lot Number: 1000120024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2023
• 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: CABLES WA00014A LOT 231W-00350 & 231W-00308.; GENERATOR WB91051W SN (B)(6).; OPTICS 12° WA2T412A SN (B )(6)& SN NOT INDICATED.; RESECTORS WA22366A X2.