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

Model Number	LF5544
Medical Device Problem Codes	Flare or Flash (2942); Noise, Audible (3273)
Health Effect - Clinical Codes	Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)
Date of Event	08/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: health professional (hpro).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device was not working and they heard a bang.A second instrument was used, but was not okay as well, because it was faulty as the tissue was burned lateral.According to the nurse with one of the instruments, while it was being used the insulation slipped off, was removed from the device, in a backward direction of the jaw and the surrounding tissue was burned.The disengaged part was removed from the device's tip and it did not fall into the patient's cavity.Localized burn of level 1-2 was caused by the non-insulated part on the jaw.Patient is fine and there were no other complications.
Additional Manufacturer Narrative
Evaluation summary: two devices were received for evaluation.The returned product did not meet specification as received.Visual inspection found the clear boot was torn, all pieces were still attached and present on one of the devices.The other device had no visual defects.The customer reported that the device was not working and they heard a bang.The reported condition was not confirmed.The investigation found the devices to function normally and within specifications.The devices were recognized when plugged into the generator.The devices were activated on a saline soaked towel with acceptable results and a visual seal effect was observed.The devices functioned normally when activated in the vlmode.No abnormal noise was heard when the devices were activated.The investigation found the device to function normally and within specifications.The reported condition was confirmed.The device failed hipot testing.The investigation identified the root cause of the reported event to be user error.The instructions for use (ifu) states to prevent damage to the flexible insulation proximal to the jaws, confirm the handle is fully closed prior to insertion into and extraction from the cannula.Use the appropriately sized cannula to allow for easy insertion and extraction of the instrument.Failure to do so may impact the integrity of the flexible insulation.Cannulas with hard, non-beveled openings may cause the flexible insulation to retract, which may compromise the insulation.If retraction occurs, the instrument must be discarded.Do not attempt to clean the flexible insulation.Cleaning may damage insulation.If information is provided in the future, a supplemental report will be issued.

• Brand Name: LIGASURE ADVANCE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7802578
• Report Number: 1717344-2018-01117
• Device Sequence Number: 1909230
• Product Code: GEI
• UDI-Device Identifier: 10884524002279
• UDI-Public: 10884524002279
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K150835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2018

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: 10/31/2020
• Device Model Number: LF5544
• Device Catalogue Number: LF5544
• Device Lot Number: 52940102X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1