MAUDE Adverse Event Report: MECTRON S.P.A. PIEZOSURGERY; PIEZOSURGERY 3

Model Number 02890008

Device Problem Defective Component (2292)

Patient Problem Burn, Thermal (2530)

Event Date 04/23/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturer required to the (b)(6) to return the device to do the related investigation.The device was not returned.

Event Description

The customer indicates: burns the mucosa of the lower left lip that immediately reaches the point of eating despite irrigation.The handpiece must be repaired.Consequences;: prolongation of surgery.

Manufacturer Narrative

The manufacturer required to the hopitaux the toulose to return the device to do the related investigation.The device was not returned.

Event Description

The customer indicates: burns the mucosa of the lower left lip that immediately reaches the point of eathing despite irrigation.The handpiece must be repaired.Consequences;: prolungation of surgery.

• Brand Name: PIEZOSURGERY
• Type of Device: PIEZOSURGERY 3
• Manufacturer (Section D): MECTRON S.P.A.; via loreto 15/a; /; carasco, genoa , italy 16042 ; IT 16042
• MDR Report Key: 8320979
• MDR Text Key: 135682070
• Report Number: 3003933619-2018-00002
• Device Sequence Number: 1
• Product Code: JDX
• Combination Product (y/n): N
• PMA/PMN Number: K091227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02890008
• Device Catalogue Number: 02890008
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR