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 10/03/2016

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 knife blade became stuck after 2 or 3 activations.The knife blade was extended and exposed as the jaws of the device were open during use.There was no injury.

Manufacturer Narrative

(b)(4).One lf1637 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 blade exposed when the jaws were open.The customer reported the knife blade was exposed and the reported condition was confirmed.The investigation found the tactile feel of the knife trigger felt normal however pulling and releasing the trigger did not affect the position of the blade.The device was disassembled and evaluated by the product engineer.The mechanical assembly in the body of the device was found to be normal.The device body showed evidence of fluid ingress indicating the device had been exposed to heavy use or reprocessing.The spindle pin, knife trigger, and latch assembly was found to have been properly installed.The exposed blade was found to be from a broken knife in the tube.The investigation identified the root cause of the reported event to be rough handling by the user causing the knife to break.The ifu states, this product cannot be adequately cleaned and/or sterilized by the user in order to facilitate safe reuse, and is therefore intended for single use.Manufacturing non-conformances were reviewed.No entries pertinent to the customer's report were noted.

• 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: 6053754
• MDR Text Key: 58307892
• Report Number: 1717344-2016-00988
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K141153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2020
• Device Model Number: LF1637
• Device Catalogue Number: LF1637
• Device Lot Number: 53530085X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2016
• 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
• Patient Age: 36 YR
• Patient Weight: 27