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

Model Number	HOL270R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No complaint sample was obtained during the timeframe for investigation despite attempts to collect the complaint sample made by the responsible sales representative.It is acknowledged that each holmium fiber unit is subject to 100% inspection prior to release which includes a verification for physical defects as well as power transmission testing with a holmium laser.An important factor is that dornier holmium fibers are fragile and must be handled with care as instructed in the dornier medtech holmium fiber ifu.The facility process for the storing the fibers prior to usage was not confirmed in the timeframe of this investigation.No manufacturing defects or inconsistencies were revealed during this investigation.The recognized likelihood of a unit being released for distribution broken is low as multiple manufacturing process controls are in place to prevent that occurrence.In this report, the unit was noticed with a break prior to use and no impact to the patient occurred.
Event or Problem Description
Complaint information was received for a holmium fiber which was identified broken out of the box prior to usage.No patient impact occurred due to this product complaint.

• 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
• MDR Report Key: 10937555
• Report Number: 1037955-2020-00044
• Device Sequence Number: 3019387
• Product Code: GEX
• UDI-Device Identifier: 00810116020447
• UDI-Public: 01008101160204471724120410F4719R
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2020

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 Expiration Date: 12/04/2024
• Device Model Number: HOL270R
• Device Lot Number: F4719R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1