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

Model Number LF1937

Device Problem Energy Output Problem (1431)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during laparoscopic total gastrectomy at first sealing, even though sealing completion tone sounded.The omentum tissue was found to be not sealed properly and felt to be half done.No regrasp alert or other error that occurred.In other laparoscopic scene (means that the sealing did not work not only when cutting the omentum but also when subsequent blood vessels were processed), the blood vessel was only about 2mm but sealing on the blood vessel failed and bleeding could not be stopped.They used a different brand of product and was able to stopped the bleeding on the patient's tissue.In was also noted that there was a total of 1500ml of bleeding, less than 200cc was due to device.The surgical time was extended by more than 30 minutes and the patient had received blood transfusion.

Manufacturer Narrative

Additional info: d10, g4, h3, h6 h3 evaluation summary: one device was received for evaluation.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.The investigation found the device to function normally and within specifications.The instructions for use(ifu) 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.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 9690157
• MDR Text Key: 178781759
• Report Number: 1717344-2020-00132
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521705913
• UDI-Public: 10884521705913
• Combination Product (y/n): N
• PMA/PMN Number: K170869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF1937
• Device Catalogue Number: LF1937
• Device Lot Number: 92700077X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Date Manufacturer Received: 02/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention