MAUDE Adverse Event Report: COVIDIEN LLC (SHANGHAI) LIGASURE ATLAS HANDSWITCHING 37CM; LIGASURE VESSEL SEALING SYSTEM

Model Number LS1037

Device Problems Device Inoperable (1663); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2014

Event Type  Injury  

Event Description

The customer had reported that during a hysterectomy, the knife blade of the device would not work.A new device was used, and there was no harm to the patient.Upon receipt of the device for evaluation at covidien, a preliminary investigation found that the insulation of the jaw wires is missing and currently unaccounted for.The customer has been notified of this finding.

Manufacturer Narrative

(b)(4).Date of initial report : 03/25/2015.Additional questions in regard to the incident have been asked.The incident device has been received and is under evaluation.When the device evaluation is complete, a follow-up report will be submitted.

Manufacturer Narrative

(b)(4).Visual inspection found damaged insulation on the grey jaw wire.The knife cut was tested on a silicone test strip.While the knife was capable of advancing, the results were unacceptable.Due to the poor cut the blade was inspected under magnification and damage to the leading edge of the blade was found.The damage is consistent with inadvertently cutting on a hard object, such as a staple.The investigation identified the root cause of the damage to be mishandling by the user.The ifu states: do not engage the cutting mechanism over clips, staples, or other metal objects as damage to the cutter may occur.An additional failure was found during the investigation: the jaw wire was damaged.The additional findings did not contribute to the reported condition.The damage to the jaw wire is consistent with scraping the jaws against the sharp edge of a trocar during insertion or removal of the device or another instrument.The investigation identified the root cause of the additional finding to be an user error.The ifu states to carefully insert and withdraw instruments from cannulas (trocars) to avoid possible damage to the devices and/or injury to the patient.

• Brand Name: LIGASURE ATLAS HANDSWITCHING 37CM
• Type of Device: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LLC (SHANGHAI); bldg 10, 789 puxing rd; shanghai 2011 14; CH 201114
• Manufacturer (Section G): COVIDIEN LLC (SHANGHAI); bldg 10, 789 puxing rd; shanghai 2011 14; CH 201114
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 4633033
• MDR Text Key: 5593866
• Report Number: 3006451981-2015-00069
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: LS1037
• Device Catalogue Number: LS1037
• Device Lot Number: S3G0033CX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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
• Patient Age: 52 YR
• Patient Weight: 65