MAUDE Adverse Event Report: GYRUS ACMI, INC CUTTING LOOP (12/PK); ELECTRODES, PROBES

Model Number MLE-24-012

Device Problems Arcing of Electrodes (2289); Defective Device (2588)

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

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated.Inspection found the shaft and proximal connector are in good condition, however, the distal insulation was severely melted and charred, exposing the internal wire.The loop is intact.The electrode was then checked with the test generator esg-400 together with the working element eiwe, gyrus telescope, inner sheath eris-cf25, and dac active cable.The electrode generated energy output at the cutting loop without an issue.There was no arcing or sparking to the reference test telescope distal tip during activation, however, the distal insulation was observed to be severely melted, charred.Based on evaluation findings the reported issue of arcing, sparking was not able to be duplicated however damage to distal insulation has been observed.The physical evaluation was not able to replicate arcing with olympus' test equipment.However, physical evidence suggests there was arcing during the customer's use due to presence of charring of insulation (severely melted) at the distal end.This report will be supplemented accordingly following investigations.

Event Description

Quantity of 3 electrodes with the same model and lot number were used during a transurethral resection of the prostate (turp) procedure.The first two (2 failed) and the third (3rd) one was used to complete the intended procedure.The electrodes were reported to be defective.There was no patient harm or injury reported due to the event.No user injury reported.This complaint is related to reports patient identifier (b)(4).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: d4,g3, g6, h2, h4,h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The user facility sales representative conveyed that the failure was most likely due to the working element.Customer was not able to provide the working element for investigation, however it was noted they replaced the working element.Therefore, the arcing experienced by the user could be due to the working element malfunctioning causing the damaged/charred insulation.Per instruction for use (ifu) it states: the device is to be used with a standard monopolar generator.If incomplete assembly of the electrode to the dac connector, not locked in place, it can resulted in an intermittent connection that could have produced arcing or sparking from the device.Olympus will continue to monitor the field performance of this device.

• Brand Name: CUTTING LOOP (12/PK)
• Type of Device: ELECTRODES, PROBES
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11711689
• MDR Text Key: 250462186
• Report Number: 3011050570-2021-00064
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 00821925036413
• UDI-Public: 00821925036413
• Combination Product (y/n): N
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MLE-24-012
• Device Lot Number: MK749375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCOPE, WORKING ELEMENT