MAUDE Adverse Event Report: COVIDIEN LP LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER; LIGASURE VESSEL SEALING SYSTEM

Model Number LF1637

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of initial report: 11/04/2016.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 shaft of the device appeared to be curved once the package was opened.There was no injury to the patient.The device was returned to covidien and initial inspection discovered that the knife was partially deployed when the jaw was opened without pulling the knife trigger.

Manufacturer Narrative

Covidien reference #: (b)(4).Date of initial report: 11/04/2016.Date of follow-up report: 12/13/2016.One lf1637 was received for evaluation.This device had not been used in the treatment of the patient.Visual inspection found the shaft to be bent.The blade of the knife partially deployed when the jaws were open without pulling the knife trigger.Engineering evaluated the device and did not identify anything in the manufacturing process which would possibly have contributed to this failure.The investigation could not determine the root cause of the customer's report.No trend has been identified.Manufacturing non-conformances were reviewed.No entries pertinent to the customer's report were noted.The ifu states, if the instrument shaft is visibly bent, discard and replace the instrument.A bent shaft may prevent the instrument from sealing or cutting properly.

• Brand Name: LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER
• 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: 6079099
• MDR Text Key: 59226453
• Report Number: 1717344-2016-01009
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521147003
• UDI-Public: 0110884521147003172007011051520298X
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K141153
• 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: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2020
• Device Model Number: LF1637
• Device Catalogue Number: LF1637
• Device Lot Number: 51520298X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1