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

Model Number	K2013151
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
Event or Problem Description
A notification was received regarding a holmium fiber unit which was reported to have broken during usage.
Additional Manufacturer Narrative
The returned complaint sample was confirmed to be broken as reported by the complainant.Upon evaluation of the unit returned, it was determined the unit was broken with a jagged characteristic, no area of burn/apparent laser energy was noted on the area of breakage.The deices rfid tag was verified and no usage was recorded on rfid.The complainant reported the laser fiber broke and the operator received a superficial burn which required no follow up treatment.However, this could not be confirmed given the laser fiber rfid indicating no usage of the returned laser fiber device.All laser fiber units manufactured by dornier are confirmed via visual inspection 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
• 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 30144 ; 7705146204
• MDR Report Key: 17764021
• Report Number: 1037955-2023-00033
• Device Sequence Number: 12536116
• Product Code: GEX
• UDI-Device Identifier: 04049958003158
• UDI-Public: 01040499580031581727012810F0322R
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2023

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
• Operator of Device: Health Professional
• Device Model Number: K2013151
• Device Lot Number: F0322R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2022
• 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