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

Model Number	LF4318
Medical Device Problem Codes	Overheating of Device (1437); Flare or Flash (2942)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	04/12/2018
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 a procedure, the surgeon and staff both observed that the device was extremely hot to touch after activation.Accordingly, they said that the heat of the jaws caused two second degree burns (blisters) on the patient¿s right side of the incision with approximately 1cm in size each.The device was not being activated against the skin.
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 reported conditions were not confirmed.Functional testing was performed with the returned device on porcine kidney tissue.Multiple seals on various size vessels were made and a full thermal effect was visually verified.The device was activated while pressing the button and with the rotation knob in various positions to detect any problematic activation issues.All seal cycles were completed satisfactorily and end tones were heard indicating completed activation cycles.No abnormal heat or burnt tissue was observed 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 ifu (instructions 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, during a procedure, the surgeon and staff both observed that the device was extremely hot to touch after activation.Accordingly, they said that the heat of the jaws caused two second degree burns (blisters) on the patient¿s right side of the incision with approximately 1cm in size each.The patient treated with a silvadene cream.The device was not being activated against the skin.

• 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: 7458692
• Report Number: 1717344-2018-00566
• Device Sequence Number: 1146784
• Product Code: GEI
• UDI-Device Identifier: 10884521165311
• UDI-Public: 10884521165311
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K123444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2018

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: 10/03/2021
• Device Model Number: LF4318
• Device Catalogue Number: LF4318
• Device Lot Number: 62780249X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1