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 Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No complaint fiber was 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 the information available it is likely it may be related to the handling of the device.
Event or Problem Description
A notification was received regarding a holmium fiber unit which was reported to have broken during use.No patient harm or impact was reported.
Additional Manufacturer Narrative
The laser fiber identified by this complaint was returned to dornier for analysis.Upon evaluation it was confirmed the returned unit was physically broken.The area of breakage was observed under magnification and it was found the fiber coating was stretched in this area.The stretching of the fiber coating indicates a physical force was placed on the unit causing the breakage to occur.No manufacturing defects or inconsistencies were identified upon review of the unit returned and production lot documentation.It is acknowledged all dornier laser fibers are subject to 100% inspection for power testing performance as well as physical defects.Laser fibers are glass, fragile, and must be handled with care as indicated on the dornier ifu for laser fibers.
Event or Problem Description
A notification was received regarding a holmium fiber unit which was reported to have broken during use.No patient harm or impact 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: 11827088
• Report Number: 1037955-2021-00023
• Device Sequence Number: 3909208
• Product Code: GEX
• UDI-Device Identifier: 04049958003097
• UDI-Public: 01040499580030971725012710F0520S
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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: 01/27/2025
• Device Model Number: K2013062
• Device Lot Number: F0520S
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1