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

Model Number LF1637

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/23/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 device was used successfully 20 times and then the device did not seem to be sealing as expected and no steam was visible.End tones, indicating a complete seal cycle, were provided by the generator in use.Another device of the same type was opened and used to complete the case.There was no bleeding or patient injury.

Manufacturer Narrative

(b)(4).Date of initial report : 01/12/2016.Date of follow-up report : 02/24/2016.The incident device was returned, evaluated and found to function within specification.The device was tested for activation and sealing function on simulated tissue with acceptable results.Additional testing was done by performing multiple seals of various sizes on porcine tissue and all seal cycles were completed satisfactorily.Covidien was unable to confirm the customer¿s report.

• 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: 5360602
• MDR Text Key: 36063691
• Report Number: 1717344-2016-00034
• Device Sequence Number: 1
• Product Code: BWA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• 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: 51520299X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2015
• 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