MAUDE Adverse Event Report: LIGASURE MARYLAND JAW W/O NAN0-COATING, 37CM; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R

Model Number LF1937

Device Problems Failure to Cut (2587); Difficult to Open or Close (2921)

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

Event Date 11/11/2022

Event Type  malfunction  

Event Description

Ligasure maryland jaws not opening all the way.Would not cut tissue.Jaws would not release once clamped on tissue.Surgeon had to manipulate hand piece to free device from tissue.Laparoscopic sealer & divider.Fda safety report id# (b)(4).

• Brand Name: LIGASURE MARYLAND JAW W/O NAN0-COATING, 37CM
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• MDR Report Key: 15805867
• MDR Text Key: 303836183
• Report Number: MW5113287
• Device Sequence Number: 1
• Product Code: NUJ
• 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: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF1937
• Device Catalogue Number: LF1937
• Device Lot Number: 14151343
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White