MAUDE Adverse Event Report: GYRUS ACMI, INC. ACMI USA ELITE SYSTEM AND USA SERIES RIGHT ANGLE CUTTING LOOP ELECTRO; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number	MLE-24-012
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During a hysteroscopy/myomectomy, a right angle cutting loop electrode was used.The cutting loop disappeared as if it disintegrated or burned off.At the time it was being used at 220 cut, 100 coag.Both the uterus and specimen were searched for any parts.Physician was confident that nothing was left behind.Device was given to material's management for return to the manufacturer.

• Brand Name: ACMI USA ELITE SYSTEM AND USA SERIES RIGHT ANGLE CUTTING LOOP ELECTRO
• Common Device Name: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 136 turnpike rd #300; southborough MA 01772
• MDR Report Key: 9915849
• Report Number: 9915849
• Device Sequence Number: 2416450
• Product Code: FAS
• UDI-Device Identifier: 00821925036413
• UDI-Public: (01)00821925036413
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2020
• Report Date (Section F): 02/04/2020

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
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 74
• Date Report Sent to FDA: 02/04/2020