MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. N/A; ELECTROSURGICAL, CUTTING COAGULATION ACCESS, LAPAROSCOPIC ENDO, REPROCESSED

Model Number LF1937

Patient Problem Insufficient Information (4580)

Event Date 02/15/2024

Event Type  malfunction  

Event Description

During operative procedure the ligasure device failed to grip the tissue the tips of the device were not closing therefore not grasping the tissue.A new device was opened and used no further issues.

• Brand Name: N/A
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESS, LAPAROSCOPIC ENDO, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 19031375
• MDR Text Key: 339230898
• Report Number: 19031375
• 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: 03/12/2024

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 Model Number: LF1937
• Device Catalogue Number: LF1937
• Device Lot Number: 15529924
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2024
• Date Report to Manufacturer: 04/03/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Race: White