MAUDE Adverse Event Report: COVIDIEN LLC LIGASURE; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number LF1212A

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2022

Event Type  malfunction  

Event Description

Covidien ligasure curved small jaw open sealer/divider ref #lf1212a lot #s1jh726x.Ligasure not working.Attempted two different machines.New ligasure dispensed to field and works properly.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 14842631
• MDR Text Key: 294864394
• Report Number: 14842631
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521186033
• UDI-Public: (01)10884521186033
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: LF1212A
• Device Lot Number: S1JH726X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15330 DA
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Race: Black Or African American