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

Model Number 03120219

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturer asked back the device for the investigation but the handpiece for plus channel, sn: (b)(4), was not returned.Not damages occurred on the patient.

Event Description

Scoliosis correction surgery in patient (b)(6) years old.Piezosurgery medical plus handpiece failed when it was connected in the piezosurgery plus.Two mt4 - 10+ inserts was used but the handpiece didn't work even so.

• Brand Name: PIEZOSURGERY
• Type of Device: HANDPIECE FOR PLUS CHANNEL PIEZOSURGERY PLUS
• Manufacturer (Section D): MECTRON S.P.A.; via loreto 15/a; carasco, genoa 16042 ; IT 16042
• Manufacturer Contact: giovanna romeo ; via loreto 15/a; carasco, genoa 16042 ; IT 16042
• MDR Report Key: 8325639
• MDR Text Key: 136241202
• Report Number: 3003933619-2018-00004
• Device Sequence Number: 1
• Product Code: JDX
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K153743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03120219
• Device Catalogue Number: 03120219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2018
• Initial Date FDA Received: 02/11/2019
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 13 YR