MAUDE Adverse Event Report: GYRUS ACMI CUTTING LOOP ELECTRODE

Model Number REF MLE 26-012

Device Problems Thermal Decomposition of Device (1071); Arcing of Electrodes (2289)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2016

Event Type  Injury  

Event Description

Right angle cutting loop electrode arched and burned a 30 degree scope.No harm to patient.Right angle cutting loop electrode removed from field.Supervisor reported that this has happened before with this particular electrode.Diagnosis or reason for use: used during turp procedure.Event abated after use stopped or dose reduced? yes.

• Brand Name: CUTTING LOOP ELECTRODE
• Type of Device: CUTTING LOOP ELECTRODE
• Manufacturer (Section D): GYRUS ACMI
• MDR Report Key: 5398043
• MDR Text Key: 37088826
• Report Number: MW5059759
• 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: 01/22/2016

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 Expiration Date: 09/30/2018
• Device Model Number: REF MLE 26-012
• Device Lot Number: 748384DF
• Other Device ID Number: REF MLE 26-012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 89