MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. N/A; ELECTROSURG, CUTTING COAG ACCESSORIES, LAPAROSCOPIC ENDOSCOPIC, REPROCESSED

Model Number LF1944

Patient Problem Insufficient Information (4580)

Event Date 08/31/2023

Event Type  malfunction  

Event Description

Surgeon inserted a reprocessed maryland ligasure ref#lf1944.He began using the device, and it only worked two times before it stopped and an error message was shown on the bovie machine.We tried to unplug it and re-plug in the ligasure but it would not work and continued to show the error message.I opened an additional reprocessed ligasure ref# lf1944.The surgeon repeated the process and it also worked one time and then gave an error message.No harm was done to the patient as the device just stopped working.Both devices were saved and placed back into their original boxes, and the boxed labeled and placed in red biohazard bags.The devices both had the same lot number and were turned into our materials manager.The materials manager pulled all of the reprocessed maryland ligasure devices that had the same lot number as the defective ones.

• Brand Name: N/A
• Type of Device: ELECTROSURG, CUTTING COAG ACCESSORIES, LAPAROSCOPIC ENDOSCOPIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 18738590
• MDR Text Key: 335751239
• Report Number: 18738590
• 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: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF1944
• Device Catalogue Number: LF1944
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Race: White