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

Model Number	K2013151
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the returned complaint sample did not reveal any manufacturing defects or root causes which would have contributed to the complaint as reported, breakage of the fiber.It is acknowledged that each holmium fiber unit is subject to 100% inspection which includes a verification for physical defects as well as power transmission testing with a holmium laser.It is acknowledged the rfid verification revealed the fiber was released operating as intended within performance specification.No reports of injury or patient outcome complications were received by dmta due to this reported complaint.Upon review of the returned fiber, it was noted the fiber coating appeared to have stretched prior to breakage.This stretching of the blue coating of the fiber is typically seen from a mechanical force placed on the fiber unit.It is acknowledged that laser fibers are fragile and must be handled with care as instructed in the dornier holmium fiber ifu.
Event or Problem Description
Complaint information was received for a holmium fiber which was identified to have broke.No reports of injury or patient complication were reported to dornier medtech america due to this product complaint.

• 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: 10680722
• Report Number: 1037955-2020-00040
• Device Sequence Number: 2975816
• Product Code: GEX
• UDI-Device Identifier: 04049958003158
• UDI-Public: 01040499580031581724060310F2
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K123385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2020

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: 06/03/2024
• Device Model Number: K2013151
• Device Lot Number: F2219R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1