MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	LS3092
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was received for evaluation.Visual inspection found one of the snaps to have broken off.Since the connector was cut off and not received, the device could not be connected to the generator and tested.The investigation could not determine the root cause of the customer's report.An additional failure was found during the investigation; one of the snaps was found to be broken and missing.The additional findings did not contribute to the reported condition.The investigation found a broken snap on the electrode jaw.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.The investigation identified the root cause of the reported event to be attributed to user error.Refer to the product instructions for use for additional information on the proper method of assembling the electrodes onto the reusable instrument.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the procedure, the device was plugged into generator and would not activate.No sound or seal would occur so another device was opened, which worked and completed the procedure.Nothing broke off during the procedure.There was no patient injury.The initial evaluation of the incident device found one of the snaps to have broken off.The broken piece was not returned.

• Brand Name: LIGASURE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 8399401
• Report Number: 3006451981-2019-00035
• Device Sequence Number: 1811421
• Product Code: GEI
• UDI-Device Identifier: 20884524002153
• UDI-Public: 20884524002153
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K981916
• 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): 03/07/2019

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 Model Number: LS3092
• Device Catalogue Number: LS3092
• Device Lot Number: 71180075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR