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

Model Number	LF4318
Medical Device Problem Codes	Retraction Problem (1536); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2018
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, during a colectomy functional end to end anastomosis procedure, the handle of the device did not return smoothly, and the knife also did not return.The device was released from the tissue by squeezing the handle a few times.The issue occurred occasionally.The device was used until the end of the procedure.There was no patient harm.
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 returned product met specification as received.Visual inspection found no defects.The reported conditions were not confirmed.The jaws opened and closed properly when the latch was retracted and released.The knife blade advanced and retracted smoothly along the knife track.The knife cut of the device was tested on a silicone test strip with acceptable results.The knife blade was also inspected under microscope and no issue was found.The investigation found the device to function normally and within specifications.The instruction for use (ifu) states, keep the instrument jaws clean.Build up of eschar may reduce sealing and/or cutting effectiveness.Wipe jaw surfaces and edges with a wet gauze pad as needed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 7574948
• Report Number: 1717344-2018-00770
• Device Sequence Number: 1529912
• Product Code: GEI
• UDI-Device Identifier: 20884521165318
• UDI-Public: 20884521165318
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 11/28/2022
• Device Model Number: LF4318
• Device Catalogue Number: LF4318
• Device Lot Number: 73330201X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 06/24/2018; 08/08/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 07/19/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1