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

Device Problems Mechanical Problem (1384); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Brain Injury (2219)

Event Date 04/16/2021

Event Type  Injury  

Event Description

According to my surgeon, dr.(b)(6) the ligasure device he used during my hysterectomy failed to seal any of the 4 major vessels he used it on.I ended up losing 4.5 liters of blood, requiring an icu stay, and due to a significant drop in blood pressure have been diagnosed with an anoxic brain injury.Per the surgeons report, the device did beep each time as expected, but the vessels were not sealed.After my inquiry to have (b)(6)investigate further, i was told that the device was destroyed when cleaning the room after surgery.I have questioned if they reported the failure, but have not been given a straight answer, so i wanted to report it here myself.Fda safety report id# (b)(4).

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 12961297
• MDR Text Key: 282040312
• Report Number: MW5105928
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability; Life Threatening
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White