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

Model Number	HOL200SBTHE
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 complaint fiber received was reviewed and it was confirmed fiber burn was apparent in the returned unit, noted at the proximal end of the fiber near the connector.The state of the fiber was consistent with comments received by the complainant.It can be confirmed holmium laser fibers are subject to 100% inspection for both visual and power testing performance defects prior to release for distribution.No manufacturing defects or contributing factors were identified upon review of the returned fiber for this complaint.No root cause for the burning of the fibers was identified however it is acknowledged the the cause is likely related to the laser device.
Event or Problem Description
A notification was received regarding a holmium fiber unit which was reported to have burned during use.No patient harm or impact was reported.

• 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: 11579017
• Report Number: 1037955-2021-00013
• Device Sequence Number: 3460407
• Product Code: GEX
• UDI-Device Identifier: 00810116020720
• UDI-Public: 01008101160207201725060810F2020S
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/26/2021

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: 06/08/2025
• Device Model Number: HOL200SBTHE
• Device Lot Number: F2020S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1