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

Model Number	LF1723
Medical Device Problem Codes	Device Alarm System (1012); Energy Output Problem (1431)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2018
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, the device was unable to prompt the correct tone, unable to seal and close the tissue and was unable to stop the bleeding.There was no patient injury.
Additional Manufacturer Narrative
One device was received for evaluation.The returned product met specification as received.Visual inspection found no defects.The reported condition was not confirmed.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.This unit does not meet the requirements for a manufacturing failure therefore a device history review is not required.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during procedure, the device had no correct tone and the surgeon did not perform the cutting operation, so the blood loss was not related to the ligasure device.After each fire, there was an alarm tone prompting to re-fire.A new device was used to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
This event has been reassessed and found to be a non-mdr reportable complaint.The issue being reported is not associated with a serious injury or potential for serious injury with reoccurrence.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: 7985052
• Report Number: 1717344-2018-01371
• Device Sequence Number: 16180189
• Product Code: GEI
• UDI-Device Identifier: 10884521181588
• UDI-Public: 10884521181588
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141153
• 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,Followup,Followup
• Report Date (Section B): 12/21/2018

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: 02/27/2022
• Device Model Number: LF1723
• Device Catalogue Number: LF1723
• Device Lot Number: 70530226X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 09/26/2018; 11/27/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 11/21/2018; 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR