MAUDE Adverse Event Report: LEONI FIBER OPTICS INC. FIBER OPTIC DELIVERY SYSTEM; POWER LASER SURGICAL INSTRUMENT

Model Number NV0627

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Type  No Answer Provided  

Event Description

We were notified by a physician that one of their pts claims to have retrieved a piece of surgical fiber from her body approx three (3) months after the procedure was performed.

• Brand Name: FIBER OPTIC DELIVERY SYSTEM
• Type of Device: POWER LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LEONI FIBER OPTICS INC. ; wiliamsburg VA 23188
• MDR Report Key: 7914263
• MDR Text Key: 122151990
• Report Number: MW5080156
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 81690102050
• UDI-Public: 81690102050
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2018

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?: No
• Device Operator: No Information
• Device Model Number: NV0627
• Device Lot Number: J41445 OR J39224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1