SYSTEM 2450 60-2450-220Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20653405058158), received between Jun 20, 2024 and Jun 20, 2024 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE: PER INFORMATION RECEIVED ON 20JUN24 THERE WAS NO REPORT FROM THE HOSPITAL FOR EQUIPMENT ALARMS SOUNDING DURING THE PROCEDURE. THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 60-2450-220, SYSTEM 2450, 220V, WAS BEING USED ON (B)(6) 2024 DURING A BLEPHAROPLASTY) AND ¿WHEN ACTIVATING THE SCALPEL, ACCORDING TO THE MEDICAL TEAM, THE SCALPEL PEN HAD A VERY STRONG FLAME, THE BLEND WAS AT A POWER OF 20 AND LOWERED TO 15 AND EVEN SO THE FLAME WHEN ACTIVATING THE PEN WAS STRONG. THE SCALPEL CARRIAGE WAS CHANGED. THE BLEND WAS REDUCED TO 10, AND WHEN USING THE SCALPEL PEN, A FLAME OF FIRE FORMED ON THE PATIENT'S FACE. THE PATIENT IS STABLE, RECEIVING DUE CARE ADMINISTERED BY THE HOSPITAL, THE BURNS ARE 2ND DEGREE IN THE REGION, CONTINUING TO THE NASAL SEPTUM. PEN USED IN OUR EQUIPMENT: SCALPEL PEN LOT: 240083 BRANDS: GABISA MEDICAL INTERNACIONAL S.A.¿. THE PROCEDURE WAS COMPLETED WITH A VALLEYLAB MEDTRONIC AND THERE WAS A 3 HOUR DELAY. PER FURTHER ASSESSMENT, IT WAS FOUND THAT BURN TREATMENT WITH SPECIAL COVERINGS WAS NECESSARY. AS OF (B)(6) 2024 THE PATIENT WAS IN TREATMENT OF THE INJURY AND ENT EVALUATION. THE PATENT DID NOT REQUIRE PROLONGED HOSPITALIZATION. THI

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19578251 ↗