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

Model Number	K2013151
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the returned complaint sample did not reveal any manufacturing defects or related factors which would have contributed to the complaint as reported, breakage of the fiber inside of a patient during operation.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 of this fiber revealed the fiber was released operating as intended with an observed power transmission above 100%.No reports of injury or patient outcome complications were received by dmta due to this reported complaint.Upon review of the returned fiber, substantial damage to the distal tip of the fiber was noted.No manufacturing defects or inconsistencies were revealed during this investigation.
Event or Problem Description
Complaint information was received for a holmium fiber which was identified to have broke inside the patient during operation.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: 10616136
• Report Number: 1037955-2020-00036
• Device Sequence Number: 13751081
• Product Code: GEX
• UDI-Device Identifier: 04049958003158
• UDI-Public: 01040499580031581724060310F2
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2020

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: 09/28/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1