MAUDE Adverse Event Report: LEONI FIBER OPTICS, INC. UROLAZE; LASER FIBER ASSEMBLY, SINGLE USE

Model Number LFS-200-RTSB

Device Problem Fracture (1260)

Patient Problem Burn(s) (1757)

Event Date 12/11/2018

Event Type  malfunction  

Event Description

Nurse reported that laser burned through the fiber and burned the surgeon's hand through his glove.The hospital refused to return unit and no other information was provided.

Manufacturer Narrative

Manufacturer notified (b)(6) 2018.Manufacturer requested unit returned for evaluation.Request was denied.Manufacturer requested more information and update on doctor's condition and if treatment had been required.No information was provided.Multiple requests were made at time of incident.No updates or information was provided to manufacturer.Adverse event report was followed up in an attempt to close the report out in 2023.Again multiple requests for more information resulted in no information given.

• Brand Name: UROLAZE
• Type of Device: LASER FIBER ASSEMBLY, SINGLE USE
• Manufacturer (Section D): LEONI FIBER OPTICS, INC.; 209 bulifants blvd.; williamsburg VA 23188
• Manufacturer (Section G): WEINERT FIBER OPTICS, INC; 215 bulifants blvd.; williamsburg VA 23188
• Manufacturer Contact: laura cole ; 209 bulifants blvd.; williamsburg, VA 23188 ; 7572594805
• MDR Report Key: 16453707
• MDR Text Key: 310366010
• Report Number: 3007336385-2018-00006
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 81690102105
• UDI-Public: 81690102105
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/13/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: LFS-200-RTSB
• Device Catalogue Number: 096249
• Device Lot Number: J42884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1