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

Model Number	HLFDBX0270C
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No complaint samples were returned for evaluation by the complainant.It can not be confirmed if the cause of the complaint as reported related to a manufacturing defect.However, 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.No reports of injury or patient outcome complications were received by dmta for to the reported complaint.Without the suspect units for evaluation, the root cause for the complaint issues as reported can not be confirmed.No manufacturing defects or inconsistencies were revealed during this investigation.
Event or Problem Description
Complaint information was received detailing two units of holmium fiber.The first unit identified was noted to be "bent on the tip" prior to use.The second fiber was identified to have "broke inside the patient".The customer stated, "this was from a box that had been opened before.It was these two laser fibers left in it".No reports of injury or patient complication was reported to dornier medtech america.

• 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,
• MDR Report Key: 10135638
• Report Number: 1037955-2020-00015
• Device Sequence Number: 17097757
• Product Code: GEX
• UDI-Device Identifier: 00810116020157
• UDI-Public: 00810116020157
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2020

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: 11/25/2024
• Device Model Number: HLFDBX0270C
• Device Lot Number: F4719S
• Was Device Available for Evaluation?: No
• Device Age: 7 MO
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2020
• Initial Report FDA Received Date: 06/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1