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

Model Number	LF1944
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Ligasure maryland jaw was in use and would not seal.No harm was done to the patient.Ligasure was removed from the field immediately and replaced.

• Brand Name: LIGASURE MARYLAND JAW
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, LAPAROSCOPIC ENDOSCOPIC, REPR
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 13618565
• Report Number: 13618565
• Device Sequence Number: 5644111
• Product Code: NUJ
• UDI-Device Identifier: 07613327504903
• UDI-Public: (01)07613327504903(17)241229(10)13476855
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/20/2022
• Report Date (Section F): 02/20/2022

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
• Operator of Device: Other
• Device Model Number: LF1944
• Device Catalogue Number: LF1944
• Device Lot Number: 13476855
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Hispanic
• Patient Race: White
• Date Report Sent to FDA: 02/20/2022