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

Model Number	HOL200S
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
The 2 returned complaint fibers were evaluated and damage at the distal tip as well as at the connector end was noted in both returned fibers.The rfid tag was found with no usage recorded while the physical state of the returned units displayed damage indicative of usage.The usage of the fibers was unable to be confirmed conclusively.It is acknowledged that all dornier fibers are subject to 100% inspection which includes a power performance testing to ensure the fiber is operating per specification and units are quality inspected visually to ensure no damage is present on units.The state of the returned fibers would not have passed dornier visual inspection requirements.The rfid tag verification concluded both units were operating within specification upon release for distribution.No manufacturing defects or process deviations were revealed.
Event or Problem Description
A notification was received regarding 2 holmium fiber units which were reported to have cracks out of packaging.

• 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: 12144586
• Report Number: 1037955-2021-00031
• Device Sequence Number: 3820162
• Product Code: GEX
• UDI-Device Identifier: 00810116020348
• UDI-Public: 01008101160203481726012010F04
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 06/09/2021

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: 01/20/2026
• Device Model Number: HOL200S
• Device Lot Number: F0421S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1