MAUDE Adverse Event Report: QUANTA SYSTEM, SPA OPTICAL FIBER 550 MICRON - SINGLE USE; POWERED LASER SURGICAL INSTRUMENT

Catalog Number	OAF005511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial reporter, the customer stated believe the laser caused excessive bleeding during 2 holeps, which lead to 2 patients being re-admitted last night for blood clots.He did request that we investigate fiber lot a253165.This is the same lot that was used when multiple blast shields blew.

• Brand Name: OPTICAL FIBER 550 MICRON - SINGLE USE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): QUANTA SYSTEM, SPA; via dell¿ acquedotto 109; samarate ; IT
• MDR Report Key: 24681594
• Report Number: 3005580113-2026-00018
• Device Sequence Number: 15946752
• Product Code: GEX
• UDI-Device Identifier: 08033945933982
• UDI-Public: 8033945933982
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2026
• Report Date (Section F): 03/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: OAF005511
• Device Lot Number: A253165
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/06/2026
• Device Age: 8 MO
• Date Report to Manufacturer: 03/06/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Date Report Sent to FDA: 03/23/2026