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

Model Number LF1944

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2019

Event Type  malfunction  

Event Description

Patient was undergoing a laparoscopic sleeve procedure.During the case, the covidien ligasure (ref # lf1944, lot # 92610146x) did not function correctly, the staples would not advance.The device was removed from the field and a new device was opened and used without incident.No patient harm.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9902950
• MDR Text Key: 185708670
• Report Number: 9902950
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521705920
• UDI-Public: (01)10884521705920(17)240916(10)92610146X
• 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: 03/13/2020

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 Model Number: LF1944
• Device Catalogue Number: LF1944
• Device Lot Number: 92610146X
• 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: 03/13/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20805 DA
• Patient Weight: 109