MAUDE Adverse Event Report: HU-FRIEDY MANUFACTURING CO., LLC PWR PIEZO LED HANDPIECE; PIEZO, ULTRASONIC

Model Number	UPHPLED
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
While using the device, the handpiece service light on the unit lit up, and the handpiece became extremely hot, causing an electric shock to the doctor's hand that was holding it.
Additional Manufacturer Narrative
The handpiece was tested on the pwr pair device and was found to be non-functional, with the handpiece indicator led continuously illuminated.The device entered fail-safe mode during testing, preventing an electric shock or overheating.The handpiece failed the insulation test and is therefore considered unusable.

• Brand Name: PWR PIEZO LED HANDPIECE
• Common Device Name: PIEZO, ULTRASONIC
• Manufacturer (Section D): HU-FRIEDY MANUFACTURING CO., LLC; 3232 n. rockwell st; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MANUFACTURING CO., LLC; 3232 n. rockwell st; chicago 60618
• Manufacturer Contact: stephanie wasielewski ; 3232 n. rockwell st; chicago, IL 60618 ; 8472574500
• MDR Report Key: 24402335
• Report Number: 1416605-2026-00001
• Device Sequence Number: 18578939
• Product Code: ELC
• UDI-Device Identifier: 10889950142728
• UDI-Public: (01)10889950142728
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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
• Operator of Device: Health Professional
• Device Model Number: UPHPLED
• Device Catalogue Number: UPHPLED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown