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

Model Number	LF5544
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104); Mechanical Problem (1384); Failure to Cut (2587); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2018
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 sacrocolpopexy, device's blade tip broke off and would not cut.Nothing fell into patient's cavity.The blade was stuck in some way and would not open anymore.There was no patient injury.
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 did not meet specification as received.The visual inspection found the knife was trapped and contained within the jaws.The jaws would not open or close due to the trapped knife.The reported condition was confirmed.The investigation found the knife is trapped and contained within the jaws.The knife is intact and no pieces are missing.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.If information is provided in the future, a supplemental report will be issued.

• Brand Name: LIGASURE ADVANCE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7455799
• Report Number: 1717344-2018-00562
• Device Sequence Number: 1636964
• Product Code: GEI
• UDI-Device Identifier: 10884524002279
• UDI-Public: 10884524002279
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K150835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2018

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: 08/17/2022
• Device Model Number: LF5544
• Device Catalogue Number: LF5544
• Device Lot Number: 72300085X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1