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

Model Number	K2016370
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No devices were returned within the duration of this investigation.The two devices identified by the complaint information have not yet been received for evaluation, although the customer has informed they may be possible to return.The root cause of the complaint as reported was not possible to confirm.However, it is acknowledged that dornier laser fibers are fragile, and must be handled with care as instructed in the applicable instructions for use for laser fibers.Should laser fibers be returned allowing further analysis, details concerning the evaluation will be provided in a follow up report.
Event or Problem Description
Two holmium fibers were reported to be damaged and broken.The customer stated regarding one unit, "fiber was visibly damaged at several points and could not be used in the procedure".The other unit was described, "fiber has been broken just before treatment when healthcare professionals were connecting it to the laser".
Event or Problem Description
Two holmium fibers were reported to be damaged and broken.
Additional Manufacturer Narrative
The suspect devices were returned to dmta and arrived on (b)(6) 2024.The two laser fibers returned were determined to be broken, consistent with information received by the complainant.It is acknowledged that dornier laser fibers are fragile, and must be handled with care as instructed in the applicable instructions for use for laser fibers.The laser fibers returned did not have any manufacturing defects or inconsistencies revealed which could have contributed to the breakage reported.It is acknowledged a mechanical force placed on the laser fibers was the likely root cause of the breakages observed.

• Brand Name: DORNIER MEDTECH AMERICA, INC.
• Common Device Name: 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, GA 30188
• MDR Report Key: 20183676
• Report Number: 1037955-2024-00036
• Device Sequence Number: 18318980
• Product Code: GEX
• UDI-Device Identifier: 00810116023462
• UDI-Public: 01008101160234621728040710F1323R
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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 Model Number: K2016370
• Device Lot Number: F1323R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown