MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. SINGLE USE SURGICAL OPTICAL FIBER

Catalog Number	OFH302711
Medical Device Problem Codes	Break (1069); Output Problem (3005)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The problem may be traced to a fiber breakage, which is a known risk already included and evaluated in the product's technical documentation and risk analysis, often attributable to inappropriate use of the device.Based on the latest updates, it is clear that an additional procedure was needed to retrieve the remaining fiber fragments in the patient following the initial treatment.Therefore, we consider this complaint reportable.
Event or Problem Description
During surgery, the device broke off inside the patient.The initial clinical procedure (lithotripsy) was completed to the best of the doctor's ability.Upon realizing the fiber had broken, the doctor attempted to retrieve it but was unsuccessful, deciding to leave the item in place.The patient returned four weeks later for surgery to remove the fragment.There were no further clinical repercussions for the patients.

• Brand Name: SINGLE USE SURGICAL OPTICAL FIBER
• Common Device Name: SURGICAL OPTICAL FIBER
• 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: 21372676
• Report Number: 3004378299-2025-00001
• Device Sequence Number: 19795715
• Product Code: GEX
• UDI-Device Identifier: 08033945937973
• UDI-Public: 08033945937973
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K180158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/13/2025

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: OFH302711
• Device Lot Number: H240134
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown