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

Model Number	LF1737
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was returned and a photograph of the device was provided for evaluation.Visual inspection noted the top jaw overmold was damaged and deformed, however, on the photograph, the top jaw did not look damaged.It was also shown on the photo that there was a tissue buildup on the top moving jaw.A piece of the damaged overmold was missing and was not returned.Functionally, the damage to the top jaw overmold likely occurred when the jaw was grasped on a metal object during activation.It was reported that the device had a component that disengaged.An associated device issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: contact between an active instrument electrode and any metal objects may increase current flow and may result in un intended surgical effects such as an effect at an unintended site or insufficient energy deposition.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, prior to use, the jaw of the device was damaged.A part of the tip had disengaged but nothing fell into the patient's cavity.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: 10254960
• Report Number: 1717344-2020-00712
• Device Sequence Number: 16813985
• Product Code: GEI
• UDI-Device Identifier: 10884521181571
• UDI-Public: 10884521181571
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K133338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2020

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: 10/18/2022
• Device Model Number: LF1737
• Device Catalogue Number: LF1737
• Device Lot Number: 72850238V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1