MAUDE Adverse Event Report: MECTRON S.P.A. PIEZOSURGERY; PIEZOSURGERY HANDPIECE

Device Problem Overheating of Device (1437)

Patient Problem Insufficient Information (4580)

Event Date 02/10/2022

Event Type  malfunction  

Manufacturer Narrative

Mectron carried out functional testing with the returned handpieces (see test report (b)(4)).No need to initiate any kind of actions because the testing results did not raise any concerns.Mectron shipped back the device to the customer and sent the outcome of the investigation with the test report on (b)(6) 2022.No root cause can be reported because the results of the functional testing carried out with the returned device, did not raise any malfunctions, defects or other issues.

Event Description

Pams get so hot and fast that you can't hold them in your hand.

Manufacturer Narrative

Mectron carried out functional testing with the returned handpieces (see test report (b)(4)).No need to initiate any kind of actions because the testing results did not raise any concerns.Mectron shipped back the device to the customer and sent the outcome of the investigation with the test report on 09/05/2022.No root cause can be reported because the results of the functional testing carried out with the returned device, did not raise any malfunctions, defects or other issues.No additional informations received from the customers therefore the complain is closed on 21/07/2022.

Event Description

Pams get so hot and fast that you can't hold them in your hand.

• Brand Name: PIEZOSURGERY
• Type of Device: PIEZOSURGERY HANDPIECE
• Manufacturer (Section D): MECTRON S.P.A.; via loreto 15/a; carasco, genoa - italy 16042 ; IT 16042
• Manufacturer (Section G): MECTRON S.P.A.; via loreto 15/a; carasco, genoa - italy 16042 ; IT 16042
• Manufacturer Contact: edoardo tronchet ; via loreto 15/a; carasco, genoa - italy 16042 ; IT 16042
• MDR Report Key: 14344894
• MDR Text Key: 299942708
• Report Number: 3003933619-2022-00002
• Device Sequence Number: 1
• Product Code: JDX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K153743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• 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: 04/10/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1