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

Model Number	LF1944
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: 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
• Report Number: 18738590
• Device Sequence Number: 15264611
• Product Code: NUJ
• UDI-Device Identifier: 07613327504903
• UDI-Public: (01)07613327504903
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2024
• Report Date (Section F): 01/04/2024

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: 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
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Race: White
• Date Report Sent to FDA: 01/04/2024