MAUDE Adverse Event Report: MEDTRONIC / COVIDIEN MEDTRONIC LIGASURE MARYLAND JAW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number LF1944

Device Problems Loss of or Failure to Bond (1068); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 12/06/2021

Event Type  malfunction  

Event Description

Physician noted having experienced equipment malfunction during a section meeting detailing prior incidences with the medtronic valleylab ligasure device; issue involved improper vessel sealing with the potential for poor/nonexistent hemostasis.Procedure was a laparoscopic gastric sleeve.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC LIGASURE MARYLAND JAW
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC / COVIDIEN
• MDR Report Key: 13152141
• MDR Text Key: 283336797
• Report Number: MW5106434
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521705920
• UDI-Public: (01)10884521705920(17)260928(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/30/2021

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 Model Number: LF1944
• Device Catalogue Number: LF1944
• Device Lot Number: 12720174X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Race: White