MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. OPTICAL FIBER REUSABLE 10X; SURGICAL LASER

Model Number	EMP-FBX272HR-C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Optical fiber broke inside patient and operator burnt his finger while retrieving it.Surgical treatment has been postponed.We are unaware about patient injury.
Event or Problem Description
Broken optical fiber caused operator's finger burn.No adverse effects to patient/operator were reported.

• Brand Name: OPTICAL FIBER REUSABLE 10X
• Common Device Name: SURGICAL LASER
• Manufacturer (Section D): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, 21017 ; IT 21017
• Manufacturer (Section G): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, 21017 ; IT 21017
• Manufacturer Contact: dario bandiera ; via acquedotto, 109; samarate, varese 21017 ; IT 21017
• MDR Report Key: 15593628
• Report Number: 3004378299-2022-00253
• Device Sequence Number: 2236631
• Product Code: GEX
• UDI-Device Identifier: 08033945938536
• UDI-Public: 08033945938536
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• PMA/510(K) Number: K180158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 10/13/2022

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 Model Number: EMP-FBX272HR-C
• Device Catalogue Number: EMP-FBX272HR-C
• Device Lot Number: H210502
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown