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

Model Number LF1944

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2023

Event Type  malfunction  

Event Description

Message from cautery: inst not recognized.

• Brand Name: N/A
• 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: 17162123
• MDR Text Key: 317466969
• Report Number: 17162123
• 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: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: LF1944
• Device Catalogue Number: LF1944
• Device Lot Number: 14594394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16425 DA
• Patient Sex: Female