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

Model Number	LS3112
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.Visual inspection found one broken jaw of the device.The broken jaw was returned.The reported condition was confirmed.The investigation found one broken jaw that was completely separated.Such jaw fracture can be caused by the user improperly applying excessive pulling pressure on the device while the jaw is caught under an object.The investigation identified the root cause of the reported event to be attributed to user error.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a procedure, the jaw was broken and the piece was removed from the patient's cavity.A new device was used to complete the procedure.There was no patient injury.

• 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: 8150493
• Report Number: 1717344-2018-01612
• Device Sequence Number: 252385
• Product Code: GEI
• UDI-Device Identifier: 10884524002514
• UDI-Public: 10884524002514
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K043273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2018

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: 05/31/2021
• Device Model Number: LS3112
• Device Catalogue Number: LS3112
• Device Lot Number: 61260171X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1