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	10/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the incident sample has not been received for evaluation.If the sample is received, or 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
The customer reported that the device was opened for a right lobectomy, cholecystectomy, wedge resection of diaphragm, ivc resection procedure but it was not used in surgery because the purple activation button had broken off.Another instrument was opened and used in surgery.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: one ls1520 was received for evaluation.Visual inspection found that the purple activation button was disengaged from the device.The customer reported a component disengaged.The reported condition was confirmed.The investigation found that the purple activation button was disengaged from the device body.No visible damage to the button or weld were found.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.A capa has been issued.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: 7108132
• Report Number: 3006451981-2017-05854
• Device Sequence Number: 86333
• Product Code: GEI
• UDI-Device Identifier: 40884524002188
• UDI-Public: 40884524002188
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K031011
• 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
• Report Date (Section B): 01/30/2018

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: 12/01/2017
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1