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

Model Number LF1637

Device Problems Difficult to Open or Close (2921); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 jaws of the device would not open while on tissue.Surgical scissors were used to remove the device.It was also reported that the knife blade was protruding from the jaws.There was no injury to the patient.

Manufacturer Narrative

(b)(4).One used lf1637 was received for evaluation.The reported condition that the jaws of the device would not open while on tissue and the knife blade was protruding from the jaws was confirmed.The rfid chip from the device was scanned and it showed that the device had been used on four separate dates.The investigation identified the root cause of the reported event to be multiple uses of a single use device.The ifu warning states, this product is designed as a single use device.It has only been evaluated in testing to simulate single-use conditions.Subjecting the product to reprocessing or multiple uses could potentially affect the structure and components which could affect the function of the device.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: 5788176
• MDR Text Key: 49381330
• Report Number: 1717344-2016-00634
• 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: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Model Number: LF1637
• Device Catalogue Number: LF1637
• Device Lot Number: 50590160X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2015
• 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