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

Model Number	K2013151
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is acknowledged each holmium laser fiber manufactured by dornier medtech is 100% inspected for both visual, and power testing performance defects prior to release for distribution.The suspect complaint fiber has not yet been obtained by dornier medtech for evaluation, however, the customer has advised the unit is available for return, and if obtained ,a review of the complaint unit will be conducted, and a final medwatch report will be submitted.This investigation has not revealed any manufacturing defects, and it is acknowledge no other complaint has been received regarding fiber burn, and the identified production lot.
Event or Problem Description
A notification was received regarding holmium fiber units (5 units), which were reported to have burned during use with 2 customer lasers.No patient harm 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: 10651859
• Report Number: 1037955-2020-00039
• Device Sequence Number: 19574137
• Product Code: GEX
• UDI-Device Identifier: 04049958003158
• UDI-Public: 01040499580031581725031110F1020R
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K123385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2020

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: 03/11/2025
• Device Model Number: K2013151
• Device Lot Number: F1020R
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1