MAUDE Adverse Event Report: COVIDIEN LP LIGASURE ADVANCE PISTOL GRIP; LIGASURE VESSEL SEALING SYSTEM

Model Number	LF5544
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date of initial report : 02/22/2016.The sample has been requested but to date the incident sample has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported that the jaws of the device would not open after activation.There was no injury to the patient.
Additional Manufacturer Narrative
(b)(4).One used (b)(4) was received for evaluation.Visual inspection found the knife is trapped and contained within the jaws.The customer reported that he jaw was unable to be opened after activation.The reported condition was confirmed.The investigation found the jaws were stuck shut due to the knife is trapped and contained within the jaws.The knife did not extend or retract when the trigger was activated.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 user error.The ifu states: the ifu cautions: do not turn the rotation wheel when the handle is fully closed and latched.Product damage may occur.Do not apply force to the shaft of the instrument causing tension or bowing as this could make the knife difficult to deploy and the trigger may not return to its normal position.The ifu states to gently pull the cutting trigger to engage the cutting mechanism.The ifu cautions confirm that the jaws have reached the closed position and are locked (the handle is latched) before activating the cutter.

• Brand Name: LIGASURE ADVANCE PISTOL GRIP
• Common Device Name: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• MDR Report Key: 5452424
• Report Number: 1717344-2016-00169
• Device Sequence Number: 12710262
• Product Code: BWA
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2016

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: 03/31/2019
• Device Model Number: LF5544
• Device Catalogue Number: LF5544
• Device Lot Number: 40860083X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2016
• Supplement Report FDA Received Date: 04/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 34