MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. MH01; SURGICAL LASER

Catalog Number PVMS00036

Device Problem Protective Measures Problem (3015)

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

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

The problem was due to a component failure.We are unaware about patient injury.We are waiting for additional information from the distributor.

Event Description

The laser system had a failure that did not allow to use it.No adverse effects to patient were reported.

Manufacturer Narrative

The problem was due to electrical/electronics components failure.We are unaware about patient injury.

Event Description

The laser system had a failure that did not allow to use it.No adverse effects to patient were reported.

• Brand Name: MH01
• Type of Device: SURGICAL LASER
• Manufacturer (Section D): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, 21017 ; IT 21017
• MDR Report Key: 8231242
• MDR Text Key: 132530531
• Report Number: 3004378299-2018-00161
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• PMA/PMN Number: K152220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: PVMS00036
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1