MAUDE Adverse Event Report: COVIDIEN LP MARYLAND JAW LAP (37CM); LIGASURE VESSEL SEALING SYSTEM

Model Number LF1737

Device Problems Failure to Advance (2524); Device Or Device Fragments Location Unknown (2590)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of initial report : 01/28/2016.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 a piece of foreign material may have fallen into the patient's cavity during the procedure and could not be located.The site believes that it is possible it came from the knife blade, but they are unable to fully confirm this at the time.The site inspected the knife but could not find a missing piece.The knife blade was having trouble advancing during the procedure, and the physician grasped the blade in an effort to advance it.This is why the site is speculating the foreign material could have been from the knife blade.This occurred after the fifth use of the device.

Manufacturer Narrative

(b)(4).Date of initial report : 01/28/2016.Date of follow-up report : 03/10/2016.The device was inspected and disassembled to verify that no components were missing.Visual inspection found no missing components.The knife cut was tested on a silicone test strip with acceptable results.The blade advanced smoothly in the knife track and returned to the home position properly.The knife was inspected under magnification and there was a gouge in the leading edge of the blade as if the surgeon cut on a staple.The ifu states, do not attempt to seal or cut over clips or staples as incomplete seals will be formed.Manufacturing non-conformances were reviewed.No entries pertinent to the customer's report were noted.

• Brand Name: MARYLAND JAW LAP (37CM)
• 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: 5397411
• MDR Text Key: 37084188
• Report Number: 1717344-2016-00095
• Device Sequence Number: 1
• Product Code: GEI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2020
• Device Model Number: LF1737
• Device Catalogue Number: LF1737
• Device Lot Number: 52090288X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2015
• 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
• Patient Outcome(s): Other