MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN LIGASURE V SEALER/DIVIDER; LIGASURE VESSEL SEALING SYSTEM

Model Number LS1500

Device Problems Component Missing (2306); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2014

Event Type  Injury  

Event Description

The customer originally reported that the device stopped working during use.No patient injury reported.Upon receipt for investigation on (b)(6) 2015, it was noted that the knife blade was broken with 0.14x 0.028 inches missing, not returned with device.The site was contacted regarding the missing component and no further details were available.

Manufacturer Narrative

(b)(4).Visual inspection noted excessive dried blood and tissue inside the jaws and in the knife track.There was excessive fluid inside the instrument as well.The device was disassembled and the blade was removed for inspection.0.16x 0.028 inches of the blade edge was found to be broken and missing.Investigation determined that the blade broke when it hit the back of the jaw during use.Improper and infrequent cleaning of the device jaws and knife track during use caused blood and tissue to build up and cake on the seal plate and in the knife track.This acted as an obstruction to the blade movement and caused it to shift slightly out of the track and hit the back of the jaw.The knife hitting the back of the jaws made it difficult for the user to unlatch the device.Forcing the device handle under this condition to open the device jaws caused the handle to break.The investigation identified the root cause of the reported event to be attributed to improper cleaning and rough handling by the user.The customer is advised to refer to the (ifu) instructions for use.The ifu recommends cleaning the instrument more often when working in a bloody field.Cleaning the jaws with a piece of wet gauze often could help minimize tissue build up between the jaws during use.No trend has been identified for this failure mode.No corrective action is required.

• Brand Name: LIGASURE V SEALER/DIVIDER
• Type of Device: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN; 10 bldg, no.789 puxing rd; shanghai 20 1 114; CH 20 1114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN; 10 bldg, no.789 puxing rd; shanghai 20 1 114; CH 20 1114
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301
• MDR Report Key: 4483479
• MDR Text Key: 20329918
• Report Number: 3006451981-2015-00029
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LS1500
• Device Catalogue Number: LS1500
• Device Lot Number: S4GB020PX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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