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

Model Number LF1937

Device Problem Failure to Seal (4070)

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

Event Date 09/14/2022

Event Type  malfunction  

Event Description

Stryker stapler did not seal the tissue when handle engaged for use.No patient harm.

• Brand Name: LIGASURE MARYLAND JAW
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, LAPAROSCOPIC ENDOSCOPIC
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 w. drake dr; tempe AZ 85283
• MDR Report Key: 15845297
• MDR Text Key: 304129289
• Report Number: 15845297
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• 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: 14069865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5840 DA
• Patient Sex: Male