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

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2020

Event Type  malfunction  

Event 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
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 136 turnpike rd #300; southborough MA 01772
• MDR Report Key: 9915849
• MDR Text Key: 186135730
• Report Number: 9915849
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 00821925036413
• UDI-Public: (01)00821925036413
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: MLE-24-012
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9855 DA
• Patient Weight: 74