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

Model Number	LF4318
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.This device had been used in the treatment or diagnosis of a patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.The reported condition was confirmed.Knife trap happens when the blade is extended and the jaws are not completely closed.This allows the knife track to open too wide and the blade moves out of its track.As a safety measure, the knife must be retracted in order to open the jaws.The tissue in the webbing may have prevented the knife from retracting far enough to allow the jaws to open.More frequent cleaning could have also reduced the difficulty activating the knife.The investigation identified the root cause of the reported event to be knife trap due to user error.The instruction for use (ifu) cautions confirm that the jaws have reached the closed position and are locked (the handle is latched) before activating the cutter.Do not overfill the jaws of the instrument with tissue.This may damage the cutting mechanism or cause the blade to deploy outside of its guiding feature, possibly resulting in difficulty opening the jaws or unintended injury to the user or patient.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a procedure the unit was faulty.The handle did not close properly.Manufacturer's visual inspection found the knife was trapped and protruding from the jaws.The jaws would not open or close due to the protruding knife.There was no patient injury or medical intervention required.

• Brand Name: LIGASURE IMPACT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7147693
• Report Number: 1717344-2017-06424
• Device Sequence Number: 19141919
• Product Code: GEI
• UDI-Device Identifier: 10884521165311
• UDI-Public: 10884521165311
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K123444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2017

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 Expiration Date: 02/22/2022
• Device Model Number: LF4318
• Device Catalogue Number: LF4318
• Device Lot Number: 70540230X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 12/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR