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	03/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.A good faith effort will be made to obtain the applicable information relevant to the report.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 would not perform an adequate seal.An end tone was heard, indicating a completed seal cycle, during use.Another generator was used but the issue continued.A new handpiece was opened and worked fine.There was no patient harm.
Additional Manufacturer Narrative
Date of initial report : 2017-04-21.Date of follow-up report: 2017-05-11.Two used ls1520 ligasure device was received, and evaluation of both returned samples could not confirm the reported issue.The customer was contacted and confirmed the issue only occurred with one of the two returned devices.Visual inspection found no defects.Both devices were activated multiple times on porcine kidney samples, pressing the button in various locations on a range of vessel sizes to detect any activation issues.All seal cycles were completed satisfactorily, and a visual seal effect with an end tone was observed for each application.The investigation found the devices to function normally and within specifications.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Hold k.O.5-10-18.

• 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: 6513558
• Report Number: 1717344-2017-05245
• Device Sequence Number: 662625
• Product Code: GEI
• UDI-Device Identifier: 20884521209265
• UDI-Public: 20884521209265
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2017

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: 08/22/2021
• Device Model Number: LF1623
• Device Catalogue Number: LF1623
• Device Lot Number: 62360258X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: Not provided; 04/21/2017
• Initial Report FDA Received Date: 04/21/2017
• Supplement Report FDA Received Date: 05/11/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1