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

Model Number	LF1744
Medical Device Problem Codes	Self-Activation or Keying (1557); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/27/2018
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, during the procedure they connected device to a generator, however an error sound was heard immediately.The generator was replaced by another generator, and the same event occurred.After that, the error sound stopped and the physician used the device as usual, however the sealing was performed without activation.Also, an activation sound was heard without pressing the button when they set the device on the surgical table.
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 device was activated ten times on a saline soaked towel with satisfactory results.All seal cycles were completed satisfactorily and end tones were heard indicating completed activation cycles.The device was activated with the rotation knob in various positions to detect any problematic activation issues.The alleged incident could not be duplicated.The investigation found the device to function normally and within specifications.The 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: 7436170
• Report Number: 1717344-2018-00497
• Device Sequence Number: 19186609
• Product Code: GEI
• UDI-Device Identifier: 20884521181561
• UDI-Public: 20884521181561
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2018

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: 08/28/2022
• Device Model Number: LF1744
• Device Catalogue Number: LF1744
• Device Lot Number: 72330167X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1