MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number LF5637

Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, approximately in the middle of the procedure, when hook was deployed, there was a jam during the activation of the grey ''clenche'' and the device jaws could not be deployed anymore properly.Surgeon tried to force it but once he was able to retract the hook, the device was not opening correctly.There was no patient injury.

Manufacturer Narrative

Evaluation summary: one device was received for evaluation.The returned product met specification as received.Visual inspection found no defects.The reported condition was not confirmed.The hook extended and retracted normally when the paddle was activated.The investigation found the device to function normally and within specifications.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, approximately in the middle of the procedure, when hook was deployed, there was a jam during the activation of the grey ''latch''.The 2nd hook was opened but it was contaminated by mistake.They opened another like device and it worked fine.There was no patient injury.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 9449934
• MDR Text Key: 170343187
• Report Number: 1717344-2019-01614
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521521735
• UDI-Public: 10884521521735
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K161804
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF5637
• Device Catalogue Number: LF5637
• Device Lot Number: 92550053X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1