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 Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint sample received 17 september 2020 was reviewed and it was confirmed fiber burn was apparent in the returned unit.The rfid tag information was reviewed which indicated the unit passed release inspection operating within specification parameters.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.It is acknowledged that the return unit was observed with charring predominately on one side of the fiber at the proximal end which is attached to the laser fiber connector.Charring on one side of a fiber is a likely sign of misaligned laser energy exposure from the customer laser.No manufacturing root cause for the burning of the fiber was identified.
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 30144
• MDR Report Key: 10650776
• Report Number: 1037955-2020-00038
• Device Sequence Number: 11504108
• Product Code: GEX
• UDI-Device Identifier: 04049958003097
• UDI-Public: 01040499580030971724110110F4419S
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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: 11/01/2024
• Device Model Number: K2013062
• Device Lot Number: F4419S
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2020
• 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