MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB FT10; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VLLS10GEN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 05/26/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, following an uneventful sleeve gastrectomy, relaparoscopy was performed for post-operative bleeding.During the second procedure, a large hematoma behind the spleen was diagnosed requiring lavage, hemostasis and drainage.The patient required a blood transfusion and their hospitalization was extended by 2 days.No further complication was reported.

• Brand Name: VALLEYLAB FT10
• 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: 10181969
• MDR Text Key: 196054503
• Report Number: 1717344-2020-00654
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521512801
• UDI-Public: 10884521512801
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/22/2020

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: VLLS10GEN
• Device Catalogue Number: VLLS10GEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/22/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention