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

Catalog Number OAF008003

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2022

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

Fiber broke inside the endoscope melting it.This event is probably due to improper handling: fiber inserted without adequate care into the endoscope.We are unaware about operator/patient injury.

• Brand Name: OPTICAL FIBER
• Type of Device: 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: 14039694
• MDR Text Key: 288790423
• Report Number: 3004378299-2022-00059
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K160513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/07/2022

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 Catalogue Number: OAF008003
• Device Lot Number: A2037180
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 04/07/2022
• 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