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

Model Number LF1937

Device Problem Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2020

Event Type  malfunction  

Event Description

During a laparoscopic hysterectomy procedure, a ligasure maryland 37cm lap sealer/ divider kept locking on tissue and would not release.Faculty surgeon checked device.Device was removed from field and sequestered.Another device was opened and procedure continued.No harm to the patient noted related to the device.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 5300 region court; lakeland FL 33815
• MDR Report Key: 10514064
• MDR Text Key: 206318066
• Report Number: 10514064
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/03/2020

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
• Device Model Number: LF1937
• Device Catalogue Number: LF1937
• Device Lot Number: 11850133
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15695 DA
• Patient Weight: 42