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

Device Problem Device Alarm System (1012)

Patient Problem Blood Loss (2597)

Event Date 08/31/2020

Event Type  malfunction  

Event Description

On august 31 - procedure: laparoscopic hysterectomy with a laparoscopic hand held device.The operation went smoothly.At the end of the operation, the area looked dry and the operation went well.Second provider began to do another operation on patient using another device which went smoothly.Half an hour later the 2nd md noted bleeding noted failure with the laparoscopic hand held device used.This is very serious.Patient could have bled to death.The only injury was more on blood loss.Patient was still in the operating room when the problem occurred.Bleeding stopped and she is stable.In addition, increased alarm of the hand held device has been noted.Covidien/medtronic aware of incident.Fda safety report id# (b)(4).

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 10534844
• MDR Text Key: 207162371
• Report Number: MW5096602
• Device Sequence Number: 1
• Product Code: GEI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 91