MAUDE Adverse Event Report: LIGASURE MARYLAND JAW; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R

Model Number LF1937

Patient Problems Adhesion(s) (1695); Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 02/08/2024

Event Type  malfunction  

Event Description

A reprocessed lf1837 maryland ligasure device was opened for a laparoscopic total hysterectomy and excision of endometriosis.As soon as the ligasure was in use an error code persisted and the ligasure did not complete seal cycles consistently when activated.The circulator was instructed to stand next to the force triad bovie and unplug/replug after every cycle to clear the error message.Malfunctioning ligasure caused a delay in the case and causing unnecessary blood loss, adhesions, and charring of tissue.Ebl 200 ml, pt discharged to home same day.Covidien.

• Brand Name: LIGASURE MARYLAND JAW
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• MDR Report Key: 18767644
• MDR Text Key: 336191747
• Report Number: MW5151856
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF1937
• Device Lot Number: 13338018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 58 KG