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

Model Number	MLE-24-012
Medical Device Problem Codes	Arcing of Electrodes (2289); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was evaluated.Inspection found charred marks on the distal ends consistent with use.Electrode was inspected under a microscope and found the shaft and proximal connector are in good condition with minor charring stains on the loop observed however, no bend on distal fork and loop is still 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.In addition, , there was no arcing or sparking to the reference test telescope distal tip during activation.The reported issue was not confirmed.Based on evaluation findings the reported issue was not confirmed as no issue found during device testing.The minor charring found on the cutting loop is most likely due to burnt tissue.This report will be supplemented accordingly following investigations.
Event or Problem 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 (arced).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)(6).
Additional 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 olympus will continue to monitor the field performance of this device.

• Brand Name: CUTTING LOOP (12/PK)
• Common Device Name: ELECTRODES, PROBES
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11711753
• Report Number: 3011050570-2021-00066
• Device Sequence Number: 3029172
• Product Code: FAS
• UDI-Device Identifier: 00821925036413
• UDI-Public: 00821925036413
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K890328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

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
• Operator of Device: No Information
• 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
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCOPE, WORKING ELEMENT