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

Model Number	LS3092
Medical Device Problem Codes	Device Alarm System (1012); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was returned for evaluation.Visual inspection noted that one plastic tab was broken and missing.Functionally, the device was attached to the re-usable metal clamp and connected to the generator showed satisfactory results.All seal cycles were completed satisfactory and end tones were heard indicating completed activation cycles.The device functioned normally and within specifications.It was reported that the device activated an alarm.An associated device issue could not be 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 product analysis detected an additional condition that was not related to the reported issue, the plastic tab was broken and missing.The product analysis noted evidence that the device was not used as intended.The instructions included with this device provide the following guidance: snap damage can be caused by the user improperly misaligning the snaps into the mating holes during assembly.This damage can also be caused by multiple assembly attempts.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 device was grasped in a gauze but alarm sounded after four seconds.The device was reconnected but it did not resolve the issue.Replaced with new similar device and it worked fine.There was no patient involved.Medtronic's initial evaluation of the incident device found that one plastic tab was broken and missing.

• 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: 10298748
• Report Number: 1717344-2020-00758
• Device Sequence Number: 3064686
• Product Code: GEI
• UDI-Device Identifier: 10884524002156
• UDI-Public: 10884524002156
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K981916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/20/2020

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: 07/16/2023
• Device Model Number: LS3092
• Device Catalogue Number: LS3092
• Device Lot Number: 81980128X
• 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: 06/23/2020
• Initial Report FDA Received Date: 07/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1