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

Model Number	K2013151
Medical Device Problem Codes	Connection Problem (2900); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned complaint samples were reviewed and it was confirmed fiber burns were apparent in both units.The rfid tags from the fibers were verified which indicated both units passed release inspection within specification.It can be confirmed each holmium laser fiber is 100% inspected 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 2 holmium fiber units returned for this complaint.Additionally, it is acknowledged one of the units returned, unit 2, was utilized for 4 treatments which does not align with the information received for the complaint fiber.It was originally reported that both of the complaint samples were used only once.The energy transmission (complainant usage) of the fiber confirmed during the review of the rfid tag for both units is objective evidence that both units were operating as intended.The state of the laser utilized with these units can not be confirmed.No root cause for the burning of the fibers was identified.
Event or Problem Description
A notification was received regarding holmium fibers reported to have burned.The complainant reported, "4 therapeutic optical fibes were burned, batch f5019r".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,
• MDR Report Key: 10246226
• Report Number: 1037955-2020-00019
• Device Sequence Number: 3093118
• Product Code: GEX
• UDI-Device Identifier: 04049958003158
• UDI-Public: 01040499580031581724121810F5019R
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2020

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: 12/18/2024
• Device Model Number: K2013151
• Device Lot Number: F5019R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Device Age: 7 MO
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1