MAUDE Adverse Event Report: MED-FIBERS, INC MED FIBERS SURGICAL LASER FIBER CURVE BALL; POWERED LASER SURGICAL INSTRUMENT

Model Number	MF800/880-SBT-2MM-CB-PEEK
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Distal piece of a laser fiber broke off and got into the bladder.Fda safety report id # (b)(4).

• Brand Name: MED FIBERS SURGICAL LASER FIBER CURVE BALL
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): MED-FIBERS, INC
• MDR Report Key: 11602863
• Report Number: MW5100489
• Device Sequence Number: 14427653
• Product Code: GEX
• UDI-Device Identifier: 00855950006233
• UDI-Public: (01)00855950006233
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/30/2021

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
• Operator of Device: Health Professional
• Device Model Number: MF800/880-SBT-2MM-CB-PEEK
• Device Catalogue Number: OD 1180 MICRON
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 87