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

Model Number WA22306D

Device Problem Material Twisted/Bent (2981)

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

Event Date 11/27/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found that the electrode was broken and the shaft was bent.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, when the olympus high frequency resection electrode was energized, the tip loop part was damaged from the base.The issue was found during therapeutic procedure.The procedure was completed with a similar device.There was no report of patient injury or medical intervention associated with this event.

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, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to usage-related wear and tear.The loop wire at the distal end of the "hf"-resection electrode wears out during use and may break, burn or melt.The following countermeasures are applicable regarding informing the user facility to prevent the reported event: caution 1: "caution risk of injury to the patient contact between the hf-resection electrode and metal parts, such as other endoscopic equipment, implants or stents can result in sparkover between the hf-resection electrode and the metal part.Always keep a distance of at least 10 mm between the hf-resection electrode and metal parts." caution 2: "caution risk of injury to the patient use extreme caution when using electrosurgery in close proximity to or in direct contact with any metal objects.Do not activate the hf-resection electrode while any portion of the hf-resection electrode tip is in contact with another metal object.This can cause uncontrolled heating of the hf-resection electrode and may result in damage and breakage to the hf-resection electrode tip.If excessive heating or physical forces cause damage to the hf-resection electrode tip, broken device fragments may remain in the body, possibly requiring additional surgery for removal." olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30°
• Type of Device: HF-RESECTION ELECTRODE
• 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: 18370991
• MDR Text Key: 331054832
• Report Number: 9610773-2023-03717
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761051689
• UDI-Public: 14042761051689
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22306D
• Device Lot Number: 1000116129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2023
• 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