MAUDE Adverse Event Report: GYRUS ACMI, INC. GYRUS ACMI; RIGHT ANGLE CUTTING LOOP ELECTRODE AND USA SERIES

Model Number MLE-26-010

Device Problems Melted (1385); Component Missing (2306); Device Or Device Fragments Location Unknown (2590)

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

Event Date 05/12/2016

Event Type  malfunction  

Event Description

During surgery we used a gyrus acmi ref# mle-26-010.Surgeon noticed the metal tip was missing.Item was removed from the surgical field and another item with same ref# was opened to finish surgery.The missing metal tip was never found because it had melted.No harm to patient.

• Brand Name: GYRUS ACMI
• Type of Device: RIGHT ANGLE CUTTING LOOP ELECTRODE AND USA SERIES
• Manufacturer (Section D): GYRUS ACMI, INC.; 136 turnpike road; southbororough MA 01772 2104
• MDR Report Key: 5688280
• MDR Text Key: 46265451
• Report Number: MW5062525
• Device Sequence Number: 1
• Product Code: FAS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/24/2016

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-26-010
• Device Lot Number: 762116GF
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR