MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. LIGASURE DEVICE; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R

Model Number LF1937

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 03/21/2023

Event Type  malfunction  

Event Description

During procedure, dr.Stated that the reprocessed ligasure device was demonstrating a short sealing cycle and questioned whether it was providing consistent energy.The device was replaced with a non-reprocessed device and the procedure was completed as scheduled.The representative was notified of the physician concern.

• Brand Name: LIGASURE DEVICE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.
• MDR Report Key: 16627879
• MDR Text Key: 312285384
• Report Number: MW5116012
• 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: 03/23/2023

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
• Device Model Number: LF1937
• Device Catalogue Number: LF1937
• Device Lot Number: 14390977
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2023
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White