MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	LF1212A
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the ligasure handle was sticking closed during use.Patient involvement information is not available.
Additional Manufacturer Narrative
Evaluation summary.One device was received for evaluation.The returned product did not meet specification as received.Visual inspection found that the knife trigger was rotated outside of its normal radius of travel.The knife was not exposed.The reported condition was not confirmed, but an additional failure mode was found.The device could be opened and closed normally.When connected to the generator, the device activated normally.The investigation found the knife trigger to have been pulled past the mechanical stop.The entire trigger assembly had rotated outside of its normal radius of travel.This mechanical damage broke the mechanical lock that prevents the knife from deploying when not depressed.The knife did not move smoothly because of the damage to the knife assembly.The investigation identified the root cause of the reported event to be the user placing excessive force on the knife trigger during use.The mechanical assembly and knife cut of the device are tested by manufacturing prior to shipment.The instructions for use (ifu) states, inspect the instrument and cords for breaks, cracks, nick, or other damage before use.Failure to observe this causation may result in injury or electrical shock to patient or surgical team or cause damage to the instrument.If damaged, do not use.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during total thyroidectomy, the device's handle was sticking closed.There was no patient injury.

• Brand Name: LIGASURE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai CO 20111 4; CN 201114
• MDR Report Key: 9911280
• Report Number: 1717344-2020-00377
• Device Sequence Number: 3272185
• Product Code: GEI
• UDI-Device Identifier: 10884521186033
• UDI-Public: 10884521186033
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K152286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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
• Operator of Device: Health Professional
• Device Model Number: LF1212A
• Device Catalogue Number: LF1212A
• Device Lot Number: S9KH704X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1