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

Model Number	LF4200
Medical Device Problem Code	Energy Output To Patient Tissue Incorrect (1209)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	06/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample was requested but to date has not been received for evaluation.If the sample or additional information pertinent to the incident is obtained, 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 activated normally but approximately 50cc's of bleeding resulted.Another device of the same type was used to continue the procedure.No serious injury occurred or medical intervention was required.
Additional Manufacturer Narrative
Evaluation summary: one used lf4200 ligasure device was received, and evaluation of the returned sample could not confirm the reported issue.Visual inspection found no defects.The device was 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 device to function normally and within specifications.There are factors during use that can affect seal quality, and the instructions for use included with this product lists measures to ensure sealing effectiveness.If information is provided in the future, a supplemental report will be issued.

• Brand Name: LIGASURE IMPACT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 6721749
• Report Number: 1717344-2017-05602
• Device Sequence Number: 187461
• Product Code: GEI
• UDI-Device Identifier: 10884521103351
• UDI-Public: 10884521103351
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K031011
• 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): 06/26/2017

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: 08/31/2017
• Device Model Number: LF4200
• Device Catalogue Number: LF4200
• Device Lot Number: 239458LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Initial Date Received by Manufacturer: 06/26/2017
• Supplement Date Received by Manufacturer: 09/22/2017
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR