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

Model Number K2013161

Device Problems Fracture (1260); No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Event Description

A notification was received regarding a holmium fiber unit which was reported to have broken during usage.

Manufacturer Narrative

No laser fiber was returned within the timeframe of this investigation and a review of suspect unit could not be completed.Upon verification of device history records, no manufacturing inconsistencies or deviations were revealed which could have caused or contributed to the complaint as reported.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.It is possible the root cause of this complaint was related to a mechanical force placed on the laser fibers which contributed to the fiber breakage reported, but without the suspect fiber this can not be confirmed.

• 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: 19089415
• MDR Text Key: 340686408
• Report Number: 1037955-2024-00008
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K2013161
• Device Lot Number: F2923S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1