MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12°; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, MONOPOLAR, REUSABLE

Model Number A22201A

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 06/28/2023

Event Type  malfunction  

Event Description

The customer reported that a spark emitted from a monopolar high-frequency cable during a therapeutic total laparoscopic hysterectomy.Smoke appeared and the wire was disconnected with an explosion sound.The hf-resection electrode, loop, 24 fr., 0.35 wire, 12° was energized during the operation, but the output was weak, and after disconnection, about 3 centimeters from the electrode part at the tip to the proximal side was burnt and darkened.The procedure was completed using similar devices.The doctor had a light burn on their hand, which they treated by cooling it down, and had not taken any medication since then.There was no harm or user injury reported due to the event.This mdr is being submitted for the reportable malfunction on the hf-resection electrode loop.

Manufacturer Narrative

The suspect device has been returned to olympus.The allegation of burning was confirmed.A piece of burnt tissue was found adhering to the electrode at the tip and rust was observed throughout.The failure location was identified to be the burnt electrode and rust.Upon checking the continuity with a tester, no energization failure was found.Therefore, the reported phenomenon alleging weak output could not be confirmed.Since rust occurred on the surface of the equipment, it was not considered to be the cause of poor conduction.Disconnection of the "a code", which is a combined device, is considered to be the cause of the current failure.The effects of reprocessing (insufficient rinsing after cleaning, chemical residue, insufficient drying, storage environment, etc.) are considered to be factors contributing to rust formation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, the root cause of the event was unable to be identified.The event likely occurred due to the usage of a defective high frequency cable.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12°
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, MONOPOLAR, REUSABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 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: 17379321
• MDR Text Key: 319588544
• Report Number: 9610773-2023-01966
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761021302
• UDI-Public: 04042761021302
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22201A
• Device Lot Number: 1000093166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: HF-CABLE, MONOPOLAR/LOT NO. 5/05.