MAUDE Adverse Event Report: CAREFUSION 2200, INC. SNOWDEN PENCER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 89-4000

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 03/05/2024

Event Type  Other  

Event Description

On behalf of karl storz endoscopy-america, inc., i¿m writing to provide clarification on an incident that occurred on (b)(6) 2024, which involved a malfunction from a hand instrument that burned the surface of a patient¿s skin during a procedure (ref.976988).Upon further investigation, our team determined that the product in question that caused an adverse event was not manufactured nor designed by karl storz endoscopy.The alleged product was a snowden pencer 89-4000.As a result, our team is not required to submit an mdr.However, i would like to acknowledge that a karl storz-lap urology tray (ksz-27717ds), was used when the user facility sterilized the non-karl storz instrument that was involved in the incident.The karl storz tray did not contribute to nor cause the malfunction and serious injury.We remain dedicated to patient safety and regulatory compliance.Please let me know if there is anything i can do to provide more clarity on this incident.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SNOWDEN PENCER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CAREFUSION 2200, INC.
• MDR Report Key: 19013372
• MDR Text Key: 339101272
• Report Number: MW5153422
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 89-4000
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2024
• Patient Sequence Number: 1