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

Model Number	K2013062
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint sample received 11 august 2020 was reviewed and it was confirmed fiber burns were very apparent in both of the returned units.The rfid tag was verified which indicated the unit passed release inspection to 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 returned fiber for this complaint.The usage confirmed during the review of the rfid tag is additional objective evidence that the fiber was operating as intended.The state of the laser utilized with this fiber can not be confirmed.No root cause for the burning of the fibers was identified.It is acknowledged that the charring on the fiber observed is predominately on one side of the fiber which is normally an indication that misaligned laser energy passed through the fiber.
Event or Problem Description
A notification was received regarding a holmium fiber which was reported to have burned.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: 10483847
• Report Number: 1037955-2020-00025
• Device Sequence Number: 14197482
• Product Code: GEX
• UDI-Device Identifier: 04049958003097
• UDI-Public: 01040499580030971724090510F3819S
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121938
• 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): 08/03/2020

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: 09/05/2024
• Device Model Number: K2013062
• Device Lot Number: F3819S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Device Age: 1 YR
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1