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

Model Number	HOL200SHE
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 upon insertion into a ureteroscope.
Additional Manufacturer Narrative
No device was returned within the timeframe of this investigation and the identified unit was confirmed by the responsible technician to not be obtainable.It is acknowledged all high energy laser fibers are 100% visually and power performance tested prior to release which confirms the operational capacity of the fibers, including properties such as the bend radius.The root cause of the complaint as reported was determined to be unrelated to the manufacturing capacity of the device, and is likely related to the operation or handling of the unit.It is possible the unit was bent past the approved radius during insertion into the scope which may have resulted in the breakage as reported, without access to the suspect laser fiber a confirmation can not be achieved.No process or material deviations were revealed upon review of the production lot records.No information regarding the scope utilized during the complaint experience was received.

• 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 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 ; 1105146204
• MDR Report Key: 15529856
• Report Number: 1037955-2022-00047
• Device Sequence Number: 2520029
• Product Code: GEX
• UDI-Device Identifier: 00810116020737
• UDI-Public: 01008101160207371727042510F1522S
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/06/2022

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: HOL200SHE
• Device Lot Number: F1522S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown