MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	LS3112
Medical Device Problem Codes	Failure to Fire (2610); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: one used ls3112 ligasure device was received, and evaluation of the sample found one broken and missing snap from the electrode jaw, however the customer reported condition was not confirmed.The returned disposable electrodes were assembled on a set of forceps.The investigation found the device to function normally and within specifications as it relates to the customer reported condition.The investigation identified that one of the snaps was broken and missing, however this additional finding did not contribute to the customer reported condition.Snap damage can be caused by the user improperly misaligning the snaps into the mating holes during assembly.This damage can also be caused by multiple assembly attempts.The investigation identified the root cause of the event to be attributed to user error.The product instructions for use contains additional information on the proper method of assembling the electrodes onto the reusable instrument to avoid damage.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device did not activate during a procedure.The reporter indicated that there was no patient injury.The incident device was returned for examination and inspection of the received device identified that one of the snaps had broken off and was not returned.Additional information has been requested to determine if the broken snap occurred during or after the procedure but no details have been provided by the facility.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: LIGASURE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7061222
• Report Number: 1717344-2017-06282
• Device Sequence Number: 1916121
• Product Code: GEI
• UDI-Device Identifier: 20884524002511
• UDI-Public: 20884524002511
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K981916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2021
• Device Model Number: LS3112
• Device Catalogue Number: LS3112
• Device Lot Number: 63270171X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 06/24/2018; 08/08/2018
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 07/20/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other