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

Model Number	K2013062
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the device available for return confirmed the unit was separated as originally reported.The probable cause of the separation of the unit was a burning which occurred likely due to errant laser energy.This was evidenced by the characteristics of the observed burning on the holmium fiber which was seen predominately on one side of the fibers proximal end.No other defects or inconsistencies were noted upon review of the returned holmium fiber.The sma housing was not provided with the returned sample and therefore a verification of the information contained on the rfid chip was not possible.It is acknowledged that all holmium fiber units are subject to 100% power testing prior to release for distribution by dmta quality to ensure capability of transmission.The state of the customer laser was not confirmed in this investigation.Regarding the second instance reported involving a breakage of the fiber which resulted in a small burn to draping and the patients thigh, as stated in the dornier holmium fiber ifu, qsf-388, "dornier singleflex¿ are fragile and must be handled with utmost care.Avoid bending or coiling fiber beyond the manufacturer recommended minimum bend radius (reference fiber specifications section); doing so may result in light leakage or fiber breakage that could cause personal injury if laser is fired (refer to laser operator's manual)." the cause of this reported experience is acknowledged to not relate to a manufacturing defect and is understood to relate to an unintended external force placed on the unit.No further updates regarding the patient condition were provided from the complainant.No serious injury was reported.
Event or Problem Description
Complainant reported two laser fibers were observed to be broken.One reportedly "separated" and the other was observed to "snap".Both instances occurred during use.

• 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: 9992800
• Report Number: 1037955-2020-00010
• Device Sequence Number: 13976388
• Product Code: GEX
• UDI-Device Identifier: 04049958003097
• UDI-Public: 01040499580030971724083010F3619S
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2024
• Device Model Number: K2013062
• Device Lot Number: F3619S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Device Age: 8 MO
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1