MAUDE Adverse Event Report: COVIDIEN COVIDIEN LIGASURE: BLUNT TIP LAPAROSCOPIC SEALER/ DIVIDER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Lot Number LF1837

Device Problem Dull, Blunt (2407)

Patient Problems Abscess (1690); Peritonitis (2252); Injury (2348)

Event Date 09/17/2020

Event Type  Injury  

Event Description

The patient underwent an uncomplicated vaginal hysterectomy for cin2/3 of the cervix and laparoscopic removal of her ovaries bilaterally.There were no lysis of adhesions or dissection near her bowel or intestines.The blunt tip ligasure device was the only cautery device used during the case only used to remove her ovaries, the remainder of the case was done vaginally.At no time was the ligasure activated or used near her bowel or her small bowel.There were no right sided pelvic trocars placed.On post op day 15 she presented to the emergency room with bloody stools, fevers, and abdominal pain.She was found to be septic.After testing she was found to have multiple abscesses and peritonitis and was taken to the operating room for exploratory laparotomy, resection of the terminal lleum and partial cecum for multiple pelvic abscesses and what was presumed to be a small bowel injury from cautery from her hysterectomy.Cautery injury was suspected due to the delayed presentation.Product used was covidien ligasure: blunt tip laparoscopic sealer/ divider 5mm-37cm ref # lf1837.Fda safety report id# (b)(4).

• Brand Name: COVIDIEN LIGASURE: BLUNT TIP LAPAROSCOPIC SEALER/ DIVIDER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 10712390
• MDR Text Key: 212542099
• Report Number: MW5097357
• Device Sequence Number: 1
• Product Code: GEI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: LF1837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 47 YR
• Patient Weight: 63