MAUDE Adverse Event Report: COVIDIEN LIGASURE IMPACT; ELECTROSURGICAL, CUTTING AND COAGULATION

Model Number (01)10884521612525

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2018

Event Type  Injury  

Event Description

Instrument grasped the tissue, but would not coagulate.No patient harm.

• Brand Name: LIGASURE IMPACT
• Type of Device: ELECTROSURGICAL, CUTTING AND COAGULATION
• Manufacturer (Section D): COVIDIEN; mansfield MA 02048
• MDR Report Key: 7493957
• MDR Text Key: 107797215
• Report Number: MW5077043
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• 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: 05/03/2018

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: 03/11/2023
• Device Model Number: (01)10884521612525
• Device Catalogue Number: (17)230311(10)
• Device Lot Number: 80710214X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 91