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

Model Number LF5644

Device Problems Defective Device (2588); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 02/18/2022

Event Type  malfunction  

Event Description

Ligasure¿ retractable l-hook laparoscopic sealer/divider (ref #: (b)(4) was opened and connected to the covidien bovie machine (sn #: (b)(4), and inserted by surgeon into patient.The patient was properly grounded with bovie pad and indicator light was green.The unit was put on tissue but the device would not operate and was showing a device error message on generator machine.Another covidien bovie machine was brought into the room and the grounding pad and ligasure device was plugged into sn (b)(4).The device was placed into the patient by the surgeon and placed on tissue, the device would not operate and the same device error was shown on this generator.The surgeon asked us to open another type of ligasure device (ref #: (b)(4) and the same process was repeated in the patient.This device would not operate either when connected to the covidien bovie machine.Both devices were placed back into their original boxes and then placed into a red bag.This has been an ongoing issue with this product.System upgrades have been placed on all bovie machines.Or management told the covidien representative about this issue once again.

Event Description

Ligasure¿ retractable l-hook laparoscopic sealer/divider (ref #: lf5644) was opened and connected to the covidien bovie machine, and inserted by surgeon into patient.The patient was properly grounded with bovie pad and indicator light was green.The unit was put on tissue but the device would not operate and was showing a device error message on generator machine.Another covidien bovie machine was brought into the room and the grounding pad and ligasure device was plugged into the covidien bovie machine.The device was placed into the patient by the surgeon and placed on tissue, the device would not operate and the same device error was shown on this generator.The surgeon asked us to open another type of ligasure device (ref #: lf5637) and the same process was repeated in the patient.This device would not operate either when connected to the covidien bovie machine.Both devices were placed back into their original boxes and then placed into a red bag.This has been an ongoing issue with this product.System upgrades have been placed on all bovie machines.Or management told the covidien representative about this issue once again.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 14110773
• MDR Text Key: 289274316
• Report Number: 14110773
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521521742
• UDI-Public: (01)10884521521742
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

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: LF5644
• Device Lot Number: 01420083X
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2022
• Date Report to Manufacturer: 04/14/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20075 DA
• Patient Sex: Female
• Patient Weight: 96 KG
• Patient Race: White