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

Model Number	LF4200
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	08/17/2017
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 had an issue with self-activation.It would activate without pressing the button.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.This device had been used in the treatment or diagnosis of a patient.Reported and outside expiration date at time of 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.No self activation occurred during the testing of the device.The alleged incident could not be duplicated.The investigation found the device to function normally and within specifications.The instruction for use 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.
Event or Problem Description
According to the reporter, intra-operatively, multiple device issues occurred.A tissue fusion open instrument was difficult to activate.An open sealer device would smoke when activated.The tissue fusion electrode device is difficult to activate.A laparoscopic device had a loose shaft, and another tissue fusion open instrument had an issue with self-activation, where the device would activate without pressing the button.There was no patient injury.

• 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: 6856889
• Report Number: 1717344-2017-05886
• Device Sequence Number: 13612204
• 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,Followup
• Report Date (Section B): 10/03/2018

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: 08/31/2017
• Device Model Number: LF4200
• Device Catalogue Number: LF4200
• Device Lot Number: 239591LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Initial Date Received by Manufacturer: 08/17/2017
• Supplement Date Received by Manufacturer: 07/18/2018; 08/08/2018
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 08/02/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1