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

Model Number SEP6000

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

Patient Problem Anemia (1706)

Event Type  Injury  

Event Description

According to the reporter, after an open abdominal surgery (laparotomy) for the mammary gland, bleeding was observed several hours after the surgery even though hemostasis was achieved during the procedure.The hemoglobin was reduced to minus 4.The anemia was then treated with fluid replacement to increase external pressure and adjust the blood pressure.Hospitalization was extended.The hematoma was then removed at an outpatient visit with an incision of approximately 3 centimeters.It was noted that the relationship between the bleed and the device was unknown and a lot of bleeding was observed during the use of sep6000 compared to the other device.

Manufacturer Narrative

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

• Brand Name: VALLEYLAB
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13196466
• MDR Text Key: 283581796
• Report Number: 1717344-2022-00034
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521750913
• UDI-Public: 10884521750913
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K182772
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SEP6000
• Device Catalogue Number: SEP6000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2021
• 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): Required Intervention; Hospitalization
• Patient Sex: Female