MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	LS1520
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively, the device had a component issue and was difficult to activate, wherein the sealing activator button cover (violet color) detached from the sealing device.It was possible to continue and complete the procedure because the surgeon was able to activate the sealer, but was more difficult because the cap fell apart during the procedure.No patient injury.
Additional Manufacturer Narrative
Evaluation summary: two devices were received for evaluation.The devices had been used in the treatment or diagnosis of the patient.A review of the lot number reported indicates that the products were within the assigned expiration date at the time of the reported incident.The returned products did not meet specification as received.Visual inspection found that the purple activation button was disengaged on both devices.One disengaged button was returned for investigation.The reported condition was confirmed.The investigation found that the purple activation button was disengaged from the device body.No visible damage were found on the devices weld or the returned activation button.Quality engineering has been notified of this type of failure before and it was determined that the disengaged purple activation button is a design issue.A design improvement plan has been initiated to address the disengaged purple activation button.The investigation identified the root cause of the reported event to be a design issue.Corrective actions have been implemented to mitigate this issue.The provided lot number indicates that this product was manufactured in shanghai.The appropriate personnel have been contacted and the manufacturing non-conformance search results will be recorded in the dhr task.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 MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 7274008
• Report Number: 3006451981-2018-00106
• Device Sequence Number: 1028850
• Product Code: GEI
• UDI-Device Identifier: 40884524002188
• UDI-Public: 40884524002188
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K043273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2018

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: 11/08/2021
• Device Model Number: LS1520
• Device Catalogue Number: LS1520
• Device Lot Number: S6LB002X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1