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

Model Number	LF5544
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2018
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 plastic sheath of the device below the tip slides up and it exposed the metal underneath.They were concerned that the exposed metal would burn the surrounding tissue.There was no patient injury.
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 laparoscopic procedure, the plastic sheath of the device below the tip slides up and it exposed the metal underneath.They were concerned that the exposed metal would burn the surrounding tissue.Another similar device was opened to complete the procedure.The scrub nurse was able to push the plastic up toward the distal end of the jaws but that was only after the case was completed.It functioned fine for the remainder of the case.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: one device sample 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 did not meet specification as received.Visual inspection found the clear insulation slid up toward the jaws.The investigation found the device failed hipot testing.The investigation identified the root cause of the reported event to be user error.The instruction 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: 7529904
• Report Number: 1717344-2018-00714
• Device Sequence Number: 1452855
• Product Code: GEI
• UDI-Device Identifier: 10884524002279
• UDI-Public: 10884524002279
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 02/28/2022
• Device Model Number: LF5544
• Device Catalogue Number: LF5544
• Device Lot Number: 70600245X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 06/13/2018; 07/10/2018; 08/08/2018
• Initial Report FDA Received Date: 05/21/2018
• Supplement Report FDA Received Date: 07/03/2018; 07/25/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1