MAUDE Adverse Event Report: STEELCO S.P.A. ID 300/2 DRYING CABINET; INSTRUMENT DRYING CABINET

Model Number	ID 300/2
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Keratitis (1944)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
While troubleshooting an id 300/2 drying cabinet that displayed an error related to the uv lamp, the technician removed the bpa filter to check if all three lamps were functioning.The technician observed the lamps for less than five seconds on three separate occasions before closing the system.Exposure to the uv light, even for these brief moments, resulted in mild photokeratitis (a sensation similar to having sand in the eyes).The irritation was temporary, with no permanent damage, and vision returned to normal.According to the doctor's note, the technician was cleared to return to work the same day.No patients were involved in this incident.
Additional Manufacturer Narrative
The service technician was not aware that he should not look into the uv lamp without protective eyewear.Personnel will be trained.Appropriate terms/codes are not available for adverse event problem categories "medical device problem code" and "investigation findings." we suggest: problem code: "problem associated with failure to use protective eyewear" investigation findings code: "inadequate training of technical service personnel.".
Additional Manufacturer Narrative
This follow-up report is being submitted to provide additional required information previously not available.The following fields have been updated: b3, b4, d4, g3, g6, h2, and h4.

• Brand Name: ID 300/2 DRYING CABINET
• Common Device Name: INSTRUMENT DRYING CABINET
• Manufacturer (Section D): STEELCO S.P.A.; via balegante, 27; riese pio x, 31019 ; IT 31019
• Manufacturer (Section G): STEELCO S.P.A.; via balegante, 27; riese pio x, 31019 ; IT 31019
• Manufacturer Contact: endriu lago ; via balegante, 27; riese pio x, 31019 ; IT 31019
• MDR Report Key: 23907476
• Report Number: 3008241044-2025-00002
• Device Sequence Number: 13060096
• Product Code: MEC
• UDI-Device Identifier: 08051520012693
• UDI-Public: 08051520012693
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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: Other
• Device Model Number: ID 300/2
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown