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

Model Number	LS2111
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used ls2111 ligasure device was received, and evaluation of the sample confirmed an issue with a missing component.Visual inspection found one of the snaps had broken off and was not returned.Snap damage can be caused by the improperly misaligning the snaps onto the corresponding holes during assembly or disassembly.This damage can also be caused by multiple assembly attempts.The investigation identified the root cause of the issue to be damage from improper assembly or disassembly.The instructions included with this device lists proper assembly methods.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that during a procedure, the device would not activate.Examination of the received device on 2017-05-25 found one of the snap pins had broken off and was not returned.The customer was notified and confirmed that no piece of the device fell within the patient.

• 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: 6647572
• Report Number: 1717344-2017-05460
• Device Sequence Number: 1082394
• Product Code: GEI
• UDI-Device Identifier: 20884524000647
• UDI-Public: 20884524000647
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K981916
• 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
• Report Date (Section B): 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: LS2111
• Device Catalogue Number: LS2111
• Device Lot Number: 61320110X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2017
• Initial Report FDA Received Date: 06/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1