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

Model Number	MLE-24-012
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
As reported, during a hysteroscopic resection therapeutic procedure, upon activation in the patient, could hear sparking from inside the patient and could smell burning of plastic.The electrode was immediately removed and replaced.The case was successfully completed with a new electrode.There was no patient harm, no user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection.Visual inspection found the electrode guiding tube and fork tubes were bent.The cutting loop was charred, and its distal insulation tubes melted.However, the shaft and its proximal end appeared to be intact and fit securely into dac active connector.The electrode was then checked with a test generator esg-400 together with the working element eiwe, and dac active cable.Olympus observed the electrode generated monopolar energy output at the cutting loop without an issue.There was no arcing or burning smell at distal tip during activation.Based on the evaluation findings, the reported complaint of sparking was not confirmed.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 observed failure is a known phenomenon caused by putting the distal end through excessive stress resulting in physical damage.The event can be prevented by following the instructions for use which state: "keep the distal tip of any electrode or cutting loop in the field of view at all times." olympus will continue to monitor field performance for this device.

• Brand Name: CUTTING LOOP (12/PK)
• Common Device Name: CUTTING LOOP
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 5082077661
• MDR Report Key: 15089876
• Report Number: 3005975494-2022-00015
• Device Sequence Number: 5101786
• Product Code: HIH
• UDI-Device Identifier: 00821925036413
• UDI-Public: 00821925036413
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

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 Model Number: MLE-24-012
• Device Lot Number: KR195558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown