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

Model Number	LF1744
Medical Device Problem Code	Energy Output To Patient Tissue Incorrect (1209)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively, the device did not seal.The seal cycle was completed but the device did not seal the vessel.An absence of a regrasp alert was noted.There was an end tone heard and evidence of energy delivery.The surgeon had to use three sutures to sew and close the vessel.No patient injury.
Additional Manufacturer Narrative
Evaluation summary one device was received for evaluation.This device had been used in the treatment or diagnosis of 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 met specification as received.Visual inspection found no defects.The reported condition was not confirmed.Functional testing was performed with the returned device on porcine kidney tissue.Multiple seals on various size vessels were made and a full thermal effect was visually verified.The device was activated while pressing the button and with the rotation knob in various positions to detect any problematic activation issues.All seal cycles were completed satisfactorily and end tones were heard indicating completed activation cycles.The investigation found the device to function normally and within specifications.The instructions for use (ifu) states, keep the instrument jaws clean.Build up of eschar may reduce sealing and/or cutting effectiveness.Wipe jaw surfaces and edges with a wet gauze pad as needed.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: 7144799
• Report Number: 1717344-2017-06420
• Device Sequence Number: 927673
• Product Code: GEI
• UDI-Device Identifier: 20884521181561
• UDI-Public: 20884521181561
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K133338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2018

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: 10/30/2022
• Device Model Number: LF1744
• Device Catalogue Number: LF1744
• Device Lot Number: 73040132V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 02/02/2018
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention