MAUDE Adverse Event Report: COVIDIEN LP LIGASURE IMPACT LF4318; LIGASURE VESSEL SEALING SYSTEM

Model Number LF4318

Device Problems Fail-Safe Problem (2936); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The incident sample was requested but to date 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 Description

The customer reported that during an exenteration procedure, the knife of the device was found to be exposed outside of the jaws.No patient injury occurred and another device was used to continue the procedure.

Manufacturer Narrative

(b)(4).One lf4318 was received for evaluation.This device had been used in the treatment or diagnosis of a patient.The returned product did not meet specification as received.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.Visual inspection found the knife is trapped and protruding from the jaws.The customer reported that the knife came out of the jaw of the instrument.The reported condition was confirmed.The knife is trapped and protruding from the jaws.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 ifu cautions confirm that the jaws have reached the closed position and are locked (the handle is latched) before activating the cutter.Do not overfill the jaws of the instrument with tissue.This may damage the cutting mechanism or cause the blade to deploy outside of its guiding feature, possibly resulting in difficulty opening the jaws or unintended injury to the user or patient.Manufacturing non-conformances were reviewed.No entries pertinent to the customer's report were noted.

• Brand Name: LIGASURE IMPACT LF4318
• Type of Device: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• Manufacturer (Section G): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 6032657
• MDR Text Key: 57562257
• Report Number: 1717344-2016-00957
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K123444
• 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: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2021
• Device Model Number: LF4318
• Device Catalogue Number: LF4318
• Device Lot Number: 61670338X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2016
• 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