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

Model Number	MLE-24-012
Medical Device Problem Code	Arcing of Electrodes (2289)
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 subject device has not yet been received for evaluation.The cause of the reported event cannot be determined.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
It was reported that during a transurethral resection of the prostate (turp) procedure, the 4 electrodes arced while using in the patient.There were no further details provided regarding the event.There was no patient infection, injury or harm reported due to the event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.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.Device return found charred marks on the distal ends consistent with use.The shaft, proximal connector, and cutting loop are in good condition, however, its distal fork was bent causing the loop to become misaligned and touched the beak when it was drawn into the test inner sheath.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 test telescope distal tip during activation.The reported complaint was not confirmed.Based on the evaluation findings, the electrode was returned as used and damaged on the distal end due to excessive force applied during use.Per instruction for use ( ifu) it states: the device is to be used with a standard monopolar generator.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.Further communication with the customer conveyed that the nurse stated that they used three (3) electrodes for the procedure.The first two (2 failed) and the third (3) one was used to finish the procedure.This report is related to reports patient identifier: (b)(6).

• 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: 11385507
• Report Number: 3011050570-2021-00046
• Device Sequence Number: 4568609
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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: Health Professional
• Device Expiration Date: 05/10/2023
• Device Model Number: MLE-24-012
• Device Catalogue Number: MLE-24-012
• Device Lot Number: MK749375
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1