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

Model Number LF4418

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 12/20/2021

Event Type  malfunction  

Event Description

Ligasure impact opened, tried to use, not working (lot no: 13244224, expiry:10/01/2024, ref no# (b)(4).

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, LAPAROSCOPIC ENDOSCOPIC, REPR
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 13618570
• MDR Text Key: 286234907
• Report Number: 13618570
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 07613327417845
• UDI-Public: (01)07613327417845(17)241001(01)13244224
• 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: 02/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: LF4418
• Device Catalogue Number: LF4418
• Device Lot Number: 13244224
• 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: 02/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8760 DA
• Patient Sex: Female
• Patient Weight: 109 KG
• Patient Ethnicity: Hispanic