MAUDE Adverse Event Report: COVIDIEN LP LIGASURE IMPACT; LIGASURE VESSEL SEALING SYSTEM

Catalog Number LF4200

Device Problems Break (1069); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.

Event Description

The customer reported that the knife blade of the device would not advance.It was not used on a patient.The device was returned to covidien and initial inspection found that the spindle cap tab was broken off-found inside the handle body.

Manufacturer Narrative

(b)(4).Date of initial report : (b)(6) 2015.Date of follow-up report : (b)(6) 2015.The knife did not extend or retract when the trigger was activated.One of the tabs on the spindle cap was found to be broken.The broken tab was found inside the handle body.The knife was bent indicating it may have been trapped between the jaws at one point.If the trigger was being activated with force and the knife was trapped, the tab on the spindle cap would break.

• Brand Name: LIGASURE IMPACT
• Type of Device: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 5153754
• MDR Text Key: 28721332
• Report Number: 1717344-2015-00724
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: LF4200
• Device Lot Number: 240491LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1