MAUDE Adverse Event Report: DORNIER MEDTECH AMERICA, INC. DORNIER HOLMIUM LASER FIBER

Model Number K2013062

Device Problem Fracture (1260)

Patient Problem Superficial (First Degree) Burn (2685)

Event Type  malfunction  

Event Description

A notification was received regarding two holmium fiber units which were reported to have broken during usage.

Manufacturer Narrative

Two broken laser fiber(s) were returned to dornier medtech america within the timeframe of this investigation.The area of breakge was evaluated on both laser fibers which revealed stretching of the fiber jacket in the fracture area.Additionally, there was damage which appears to have been caused by errant laser energy in the fracture area on one of the fibers.The rfid tag was verified for both used units returned, which confirmed the devices were both connected and engaged with the customer laser prior to the breakages identified.It is confirmed that all laser fiber units manufactured by dornier are 100% inspected via visual evaluation as well as power performance testing prior to release for distribution which confirms the operational capacity as well as the state of the device.Dornier laser fibers are fragile, and must be handled with care as indicated on the valid dornier laser fiber ifu.No manufacturing defects were revealed during this investigation.It is likely the root cause of this complaint was related to a mechanical force placed on the laser fibers which caused or contributed to the fiber breakages.

• Brand Name: DORNIER HOLMIUM LASER FIBER
• Type of Device: HOLMIUM LASER FIBER
• Manufacturer (Section D): DORNIER MEDTECH AMERICA, INC.; 1155 roberts blvd; suite 100; kennesaw GA 30144
• Manufacturer (Section G): DORNIER MEDTECH AMERICA, INC.; 1155 roberts blvd; suite 100; kennesaw GA 30144
• Manufacturer Contact: amber stallings ; 1155 roberts blvd; suite 100; kennesaw 30144 ; 7705146204
• MDR Report Key: 18661777
• MDR Text Key: 334794314
• Report Number: 1037955-2024-00001
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2024

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 Model Number: K2013062
• Device Lot Number: F1523S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1