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

Model Number LF1944

Device Problems Energy Output Problem (1431); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 07/24/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, intra-operative, patient underwent a lap gastric sleeve.While in recovery, patient was found to be bleeding internally and needed to be brought back to the or.Because of the patient's deteriorating health, a lap approach was aborted and the surgeon converted to an open procedure.The bleeding was found in the short gastrics near the spleen and subsequently stopped.A blood transfusion consisting of 4 units was required.Patient stayed in the hospital for 5 extra days and is now home.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 10426927
• MDR Text Key: 203643573
• Report Number: 1717344-2020-00896
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521705920
• UDI-Public: 10884521705920
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/19/2020

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
• Device Operator: Health Professional
• Device Model Number: LF1944
• Device Catalogue Number: LF1944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention