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

Model Number	LF1744
Medical Device Problem Codes	Retraction Problem (1536); Difficult to Open or Close (2921); Mechanical Jam (2983)
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Date of Event	11/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the event occurred during the robot assisted surgery for prostate cancer.When the device was used to seal the tissue at the 1st sealing, the knife did not return and the jaws did not open.Even tried to release the jaws, the jaws could not be opened, so a new device was opened and it was used to seal the tissue around the jaws of reported device.The reported device was removed from the cavity.The device was removed from the tissue by additionally resecting the tissue.Then the operation was completed without any delay.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned product met specification as received.Visual inspection found no defects.The reported conditions were not confirmed.The jaws opened and closed properly when the handle was retracted and released.The knife blade advanced and retracted smoothly along the knife track.The knife cut of the device was tested on a silicone test strip with acceptable results.The knife blade was also inspected under microscope and no issue was found.Functional testing was performed with the returned device on porcine kidney tissue.Multiple seals on various size vessels were made.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.There was no tissue sticking or locking during the testing of the device.The investigation found the device to function normally and within specifications.The instruction for use (ifu) states, keep the instrument jaws clean.Buildup 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, the event occurred during the robot assisted surgery for prostate cancer.When the device was used to seal the tissue at the 1st sealing, the knife did not return and the jaws did not open.Even tried to release the jaws, the jaws could not be opened, so a new device was opened and it was used to seal the tissue around the jaws of reported device.The reported device was removed from the cavity.The device was removed from the tissue by additionally resecting a 5mm tissue.No blood loss was reported and there was no blood transfusion.Then the operation was completed without any delay.

• Brand Name: LIGASURE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 8119678
• Report Number: 1717344-2018-01566
• Device Sequence Number: 264783
• Product Code: GEI
• UDI-Device Identifier: 10884521181564
• UDI-Public: 10884521181564
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/20/2022
• Device Model Number: LF1744
• Device Catalogue Number: LF1744
• Device Lot Number: 73550223V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 01/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention