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

Model Number	LF1623
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	11/15/2017
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
The customer reported that during a procedure, the device had an issue with inadequate sealing.The instrument was in use with a forcetriad generator, and the issue continued when tested with an ls10 generator.A new device was connected to the generator and had no issue with sealing.There were no regrasp alarms or evidence of energy delivery, but an end tone was heard.No patient injury resulted from the issue.
Additional Manufacturer Narrative
Correction: evaluation summary one device was received for evaluation.The devices had been used in the treatment or diagnosis of a patient.A review of the lot number reported indicates that the product were 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 were 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: 7123508
• Report Number: 1717344-2017-06378
• Device Sequence Number: 11042729
• Product Code: GEI
• UDI-Device Identifier: 20884521209265
• UDI-Public: 20884521209265
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142929
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

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: 05/02/2022
• Device Model Number: LF1623
• Device Catalogue Number: LF1623
• Device Lot Number: 71230161X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1