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

Model Number	LF1744
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2017
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
The customer reported that after approximately two hours of use, the lower right section of the jaws became damaged and disengaged.The device worked fine prior to the issue.The issue was noticed after the device was released from the trocar.Nothing fell into the patient cavity.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: the product was not returned; however, a picture was provided by the customer for analysis.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 product in the picture did not meet specification.Visual inspection found the bottom jaw overmold and seal plate were damaged.The reported condition was confirmed.The seal plate and overmold was lifted from the device jaw.The damage to the jaw's overmold and seal plate likely occurred during the insertion or extraction of the device jaw from a trocar instrument.The investigation identified the root cause of the reported event to be user error.The instructions for use(ifu) states, close jaws using device lever before insertion/extraction in the trocar.Correction: additional information: if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that after approximately two hours of use, the lower right section of the jaws became damaged and disengaged.The device worked fine prior to the issue.The issue was noticed after the device was released from the trocar.Nothing fell into the patient cavity.A new device was used to continue the procedure without any patient harm.

• 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: 7148886
• Report Number: 1717344-2017-06427
• Device Sequence Number: 1238846
• Product Code: GEI
• UDI-Device Identifier: 20884521181561
• UDI-Public: 20884521181561
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2018

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: 08/09/2022
• Device Model Number: LF1744
• Device Catalogue Number: LF1744
• Device Lot Number: 72220270V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1