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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No complaint fibers were received within the timeframe of investigation.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 process deviations were identified upon review of the complaint production lot records.The root cause of this complaint was not confirmed but with consideration of the information available it is likely it may be related to the state of the customer laser, such as alignment, or also the re-sterilization process conducted on the fibers identified.
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.Additional complaint experiences were reported by the same customer, laser devices not recognizing fibers, fibers not transmitting power properly, loose connectors, fibers not working.A total of 7 units were reported for three separate production lots of fibers under two different product id's.K2013151, lot f0120r - 3 units.K2013152 lot b1018r - 3 units.K2013151 lot f0320r - 1 unit.

• 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: 11609281
• Report Number: 1037955-2021-00016
• Device Sequence Number: 11583159
• Product Code: GEX
• UDI-Device Identifier: 04049958003158
• UDI-Public: 01040499580031581725012110F0120R
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2021

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: 01/21/2025
• Device Model Number: K2013151
• Device Lot Number: F0120R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1