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

Model Number LF5544

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2016

Event Type  malfunction  

Manufacturer Narrative

Covidien reference # : (b)(4).Date of initial report : 03/07/2016.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 Description

The customer reported that the clear insulation towards the jaws became cracked during the procedure.A new device was opened to complete procedure and there was no patient injury.

Manufacturer Narrative

(b)(4).One used lf5544 was received for evaluation.Visual inspection found the clear insulation was missing from the device.The insulation piece was not returned.The customer reported that the plastic on end of device cracked during procedure.The reported condition was confirmed.The sample failed hipot testing.The investigation identified the root cause of the investigation findings to be user error.The ifu states to prevent damage to the flexible insulation proximal to the jaws, confirm the handle is fully closed prior to insertion into and extraction from the cannula.Use the appropriately sized cannula to allow for easy insertion and extraction of the instrument.Failure to do so may impact the integrity of the flexible insulation.Cannulas with hard, non-beveled openings may cause the flexible insulation to retract, which may compromise the insulation.If retraction occurs, the instrument must be discarded.Do not attempt to clean the flexible insulation.Cleaning may damage the insulation.

• Brand Name: LIGASURE ADVANCE PISTOL GRIP
• 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: 5484831
• MDR Text Key: 40029667
• Report Number: 1717344-2016-00218
• Device Sequence Number: 1
• Product Code: BWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF5544
• Device Catalogue Number: LF5544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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