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

Model Number	HOL270S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Type of Reportable Event	Malfunction
Event or Problem Description
A laser fiber was reported to have broken during usage, causing a superficial burn to the doctor's finger.No follow up or treatement was determined to be mandatory due to the superficial burn.No further impact was reported to dmta as a result of the complaint as reported.
Additional Manufacturer Narrative
The unit returned was evaluated and the area of breakage was observed under magnification.No process deviations or manufacturing defects were revealed upon review of the returned suspect device and the device records did not contain any deviation in process or material for the identified production lot.It is acknowledged all holmium fibers are 100% power tested and visually inspected prior to release which confirms the operational capacity and state of the fiber.Additionally, customer usage was recorded on the rfid for over 9000j of total energy usage, displaying furthe operational capacity of the laser fiber.It is acknowledged the likely root cause was related to a mechanical force being placed on the holmium laser fiber.Dornier laser fibers are fragile and must be handled with care as instructed on the dornier laser fiber ifu.

• 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, GA 30144 ; 7705146204
• MDR Report Key: 15384341
• Report Number: 1037955-2022-00039
• Device Sequence Number: 17519412
• Product Code: GEX
• UDI-Device Identifier: 00810116020355
• UDI-Public: 01008101160203551727041810F1522S
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K121938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/09/2022

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: HOL270S
• Device Lot Number: F0522S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown