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

Model Number	LS3112
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One device was received for evaluation.This device had been used in the treatment or diagnosis of a patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.The reported condition was not confirmed.The device was recognized and activated normally when tested.No alarms occurred and an end tone was heard each time indicating a completed seal.An alternative and reportable issue was identified, where one of the snap pins had broken off and was not returned.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 reported event to be attributed to user error.Refer to the product instructions for use (ifu) for additional information on the proper method of assembling the electrodes onto the reusable instrument.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, there was a sealing issue with the device.The device would activate and continue to seal but would not reach an end tone.An alarm would occur.There was no patient injury.Examination of the received sample found one of the snap pins from the jaws of the device had broken off and was not returned.
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: 7291029
• Report Number: 1717344-2018-00258
• Device Sequence Number: 11104557
• Product Code: GEI
• UDI-Device Identifier: 20884524002511
• UDI-Public: 20884524002511
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K043273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2018

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: 03/29/2022
• Device Model Number: LS3112
• Device Catalogue Number: LS3112
• Device Lot Number: 70890155X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Initial Date Received by Manufacturer: 01/28/2018
• Supplement Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 03/19/2018
• 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
• Patient Age: 38 YR