MAUDE Adverse Event Report: COVIDIEN LP LIGASURE V SEALER/DIVIDER; LIGASURE VESSEL SEALING SYSTEM

Catalog Number LS1500

Device Problems Break (1069); Component Missing (2306); Defective Device (2588); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

The customer originally reported, the ls1500 device was defective, no additional details were made available from the site.When the device sample was received for investigation on (b)(4) 2014, it was noted that there was damage to the knife blade edge and.04 inches of the blade was missing.The site was contacted regarding the missing knife components, but to date, has not been able to confirm the location of the missing components.If additional information pertinent to the incident is obtained a follow-up report will be submitted.

Manufacturer Narrative

(b)(4).The device was tested on simulated tissue for activation and knife function.The device functioned normally when activated but the knife would not cut smoothly.Examination under magnification confirmed damage to the leading edge of the blade.The blade was found to have 0.04 inches broken and missing.It is possible the customer hit a staple, metal pin or other hard substance that damaged the blade.The ifu for this product has a warning not to deploy the cutter on clips, staples and other metal objects to prevent damage to the cutter blade.The ifu also recommends cleaning the jaws with a piece of wet gauze to help minimize tissue build-up between the jaws.

• Brand Name: LIGASURE V SEALER/DIVIDER
• Type of Device: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow dr.; boulder CO 80301
• Manufacturer Contact: sharon murphy, sr, director pmv ; 5920 longbow dr.; boulder, CO 80301 ; 2034925267
• MDR Report Key: 3893995
• MDR Text Key: 16181115
• Report Number: 1717344-2014-00510
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Catalogue Number: LS1500
• Device Lot Number: S4BB015RAX
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/05/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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