MAUDE Adverse Event Report: MECTRON S.P.A. COMPACT PIEZO P2K; INSTRUMENT, SURGICAL, SONIC AND ACCESSORY/ATTACHMENT

Device Problem Energy Output Problem (1431)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 07/21/2022

Event Type  malfunction  

Event Description

The doctor says that while working, the scaler handpiece and tip generate a kind of "power surge" flow, but this is not related to the effectiveness of breaking up tartar deposits.The discomfort is reported by the operator's doctor (uncomfortable feeling in the hand) and the patient's pain.The client works only with original tips.The problem with the scaler was reported by the doctor from the very beginning of the installation of the scaler in the unit.The scaler installations were checked by the authorized unit service several times.For more information to the mectron test report (b)(4).Fda safety report id# (b)(4).

• Brand Name: COMPACT PIEZO P2K
• Type of Device: INSTRUMENT, SURGICAL, SONIC AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): MECTRON S.P.A.; carasco, ge 16042 ; IT 16042
• MDR Report Key: 15084949
• MDR Text Key: 296397327
• Report Number: MW5111049
• Device Sequence Number: 1
• Product Code: JDX
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Female