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

Model Number	LF1744
Medical Device Problem Codes	Material Fragmentation (1261); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2018
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, the hand instrument was connected to the generator and the sealing could be performed without problem.However, in the middle of the operation, the fragments like insulation part fell into the patient's cavity and all the fragments were collected by forceps.To deal with the event, a new device was opened and used without problem.No patient harm.
Additional Manufacturer Narrative
Additional information:evaluation summary: one device was received for evaluation.The returned product did not meet specification as received.Visual inspection found the bottom jaw over mold was damaged and missing plastic.The disengaged plastic was not returned.The reported condition was confirmed.The investigation found the bottom jaw over mold was damaged and missing plastic near the hinge of the device.The damage to the jaw's over mold 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 instruction for use states, carefully insert and withdraw the instrument through the cannula to avoid damage to the device and or injury to the patient.Close jaws using device handle before insertion/extraction in the trocar.Corrective actions have been implemented to mitigate this issue.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: 8104776
• Report Number: 1717344-2018-01543
• Device Sequence Number: 1961632
• Product Code: GEI
• UDI-Device Identifier: 10884521181564
• UDI-Public: 10884521181564
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2019

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: 12/20/2022
• Device Model Number: LF1744
• Device Catalogue Number: LF1744
• Device Lot Number: 73550223V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1