MAUDE Adverse Event Report: Hu-Friedy Mfg Co LLC PWR Piezo; PWR Piezo Unit

Model Number	UPPIEZO
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Piezo unit not working consistently.No water will come out of handpiece and patient stated they would feel "zing" feeling that hurt.Office stopped using the unit.
Additional Manufacturer Narrative
The handpiece (s/n: (b)(6)) was inspected and found to exhibit normal wear consistent with regular use.Minor cracks were observed around the edge of the handpiece connector; however, these are not considered to be the cause of the reported issue.The tip threading remains in good condition, and the tip fits securely with no abnormalities observed.The handpiece also underwent an insulation test and passed without any issues.The device handpiece cord was inspected, and no damaged, torn, or detached wires were observed at the connector.Such damage could potentially contribute to electrical shock or improper handpiece operation, which may result in the handpiece or tip indicator symbol illuminating on the display screen.However, no such indication was observed during this inspection.The device (s/n (b)(6)) and handpiece were tested for two hours and one hour, respectively, using both endodontic and perio/scaler settings on a metal test surface without water.This testing method was performed to evaluate for any potential electrical discharge or sparking from the handpiece when in contact with the metal surface, which could indicate an electrical fault transferring current from the device to the handpiece.No sparking or abnormal electrical activity was observed during the testing period.The device grounding wires were inspected and found to be securely connected and properly positioned.The grounding conductor provides a low-resistance path to earth in the event of an electrical fault, helping to reduce the risk of electric shock.No issues were identified with the grounding wires during inspection.No issues were identified during inspection, and the reported problem could not be duplicated during testing.

• Brand Name: PWR Piezo
• Common Device Name: PWR Piezo Unit
• Manufacturer (Section D): Hu-Friedy Mfg Co LLC; 2501 sanders rd; northbrook IL 60062
• Manufacturer (Section G): Mectron S.P.A.; via loreto 15/a; carasco, genoa 16042 ; IT 16042
• Manufacturer Contact: manuela galliano ; via loreto 15/a; carasco, genoa 16042 ; IT 16042
• MDR Report Key: 50235132
• Report Number: 1416605-2026-00016
• Device Sequence Number: 10344853
• Product Code: ELC
• UDI-Device Identifier: 10889950142568
• UDI-Public: (01)10889950142568
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K140965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

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: UPPIEZO
• Device Catalogue Number: UPPIEZO
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/13/2026
• 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