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

Model Number	LS2111
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was received for evaluation.This device had been removed from it's packaging by the customer however it had not been used on a patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.The returned product did not meet specification as received.Visual inspection found all of the snaps on one of the electrodes had broken off and were missing.The reported condition was confirmed.The investigation found all of the snaps had broken off one of the electrode.The snaps were not returned.The damage prevented the electrode from being correctly assembled onto a set of forceps.In this conditions the jaws of the device could not be correctly closed or opened.Snap damage can be caused by the user improperly misaligning the snaps into the mating holes during assembly or disassembly.This damage can also be caused by multiple assembly attempts.The device could not be tested for activation as received.The investigation identified the root cause of the reported event to be user damage.Refer to the product instruction for use for 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 the device jaw was difficult/impossible to close.There was no patient involvement.Manufacturer's initial evaluation of the incident device found all of the snaps on one of the electrodes had broken off and were missing.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.This device had been removed from it's packaging by the customer however it had not been used on a patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.The returned product did not meet specification as received.Visual inspection found all of the snaps on one of the electrodes had broken off and were missing.The reported condition was confirmed.The investigation found all of the snaps had broken off one of the electrode.The snaps were not returned.The damage prevented the electrode from being correctly assembled onto a set of forceps.In this conditions the jaws of the device could not be correctly closed or opened.Snap damage can be caused by the user improperly misaligning the snaps into the mating holes during assembly or disassembly.This damage can also be caused by multiple assembly attempts.The device could not be tested for activation as received.The investigation identified the root cause of the reported event to be user damage.If information is provided in the future, a supplemental report will be issued.

• 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: 7245607
• Report Number: 1717344-2018-00181
• Device Sequence Number: 1029422
• Product Code: GEI
• UDI-Device Identifier: 20884524000647
• UDI-Public: 20884524000647
• 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: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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: 09/14/2021
• Device Model Number: LS2111
• Device Catalogue Number: LS2111
• Device Lot Number: 62590077X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Initial Date Received by Manufacturer: 01/28/2018
• Supplement Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1