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 : (b)(6) 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 knife blade was found to be outside of the jaws after 3 to 4 times of use.There was no injury to the patient.

Manufacturer Narrative

(b)(4).The reported condition that the knife blade was found to be outside of the jaws was confirmed.The investigation found that the blade was extended into the knife slot but would not return to home position when the latch and jaws were opened.Upon further examination, the blade was found to be rusted and broken.The rfid chip was scanned and the device was found to be used multiple times on four separate dates.The investigation identified the root cause of the reported event to be multiple uses of a single use device resulting in product failure.The ifu warning 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: 5986338
• MDR Text Key: 55881424
• Report Number: 1717344-2016-00901
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Model Number: LF1637
• Device Catalogue Number: LF1637
• Device Lot Number: 53250090X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2016
• 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