MAUDE Adverse Event Report: DORNIER MEDTECH AMERICA, INC.; RFID HOLMIUM LIGHTGUIDE 270 MICRON

Model Number HLFD0270C

Device Problems Break (1069); Thermal Decomposition of Device (1071)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2015

Event Type  malfunction  

Event Description

Surgeon using laser fiber, for kidney stone, and the fiber broke, burning the drape.It did not touch the pt.

• Type of Device: RFID HOLMIUM LIGHTGUIDE 270 MICRON
• Manufacturer (Section D): DORNIER MEDTECH AMERICA, INC.; 1155 roberts blvd; kennesaw GA 30144
• MDR Report Key: 5324336
• MDR Text Key: 34332342
• Report Number: MW5058695
• Device Sequence Number: 1
• Product Code: FST
• 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: 12/18/2015

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 Operator: Health Professional
• Device Expiration Date: 07/08/2020
• Device Model Number: HLFD0270C
• Device Catalogue Number: HLFD0270C
• Device Lot Number: F2715S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1