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

Model Number	LF1637
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.No information regarding the customer issue that occurred with the device was available.Upon examination of the sample, it was found that the unit had an insulation failure.The product analysis noted evidence that the device was not used as intended.Damage to the rod insulation may occur during the insertion or extraction of the device jaw from a trocar instrument.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: use appropriately sized trocar to allow easy insertion and extraction of the instrument.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Device was returned without any accompanying complaint information.Initial visual inspection found the black rod insulation of the device was damaged and disengaged.The disengaged insulation was returned.

• 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: 10459637
• Report Number: 1717344-2020-00943
• Device Sequence Number: 2391526
• Product Code: GEI
• UDI-Device Identifier: 10884521147003
• UDI-Public: 10884521147003
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K130744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

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: 10/31/2023
• Device Model Number: LF1637
• Device Catalogue Number: LF1637
• Device Lot Number: 83050251X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1