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

Model Number K2014232

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

No laser fiber(s) were returned to dornier medtech america within the timeframe of this investigation.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 fiber which caused or contributed to a fiber breakage.

• 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: 18538876
• MDR Text Key: 333219458
• Report Number: 1037955-2023-00059
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123385
• 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: 12/22/2023

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: K2014232
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1