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

Model Number LF4418

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2022

Event Type  malfunction  

Event Description

Ligasure impact reprocessed by stryers, never worked from initial plug in.No sound, no current.We had to open another device.

• Brand Name: STRYKER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 15958445
• MDR Text Key: 305249998
• Report Number: 15958445
• 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: 12/06/2022,11/29/2022

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
• Device Model Number: LF4418
• Device Catalogue Number: LF4418
• Device Lot Number: 13468290
• 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: 12/06/2022
• Date Report to Manufacturer: 12/12/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29200 DA
• Patient Sex: Male