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

Model Number	DORNIER SINGLEFLEX 200
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fiber was evaluated, and it was noted a break occurred at approximately 11 inches from the distal tip.The returned sample was re-cleaved and tested to release specifications.The observed values during the evaluation were noted to be within specification and no failures were noted.It is acknowledged the rfid scan indicates the fiber was power tested, and released within specification on 1 july 2019.As evidenced by the last use indication from the rfid scan indicating a power setting of 15 watts and a total energy accumulated of 3120 joules, it can be calculated the facility utilized this fiber for approximately 3.5 minutes.These confirmations demonstrate it is very unlikely there were any manufacturing faults with the fiber.The cause of the fiber break was unable to be confirmed, but it is acknowledged no manufacturing defects were identified in this investigation, which could have contributed to the complaint as reported.The root cause of the breakage is recognized to relate to the clinical application of the device.As stated in the dornier singleflex laser fiber single use holmium fiber instructions for use, "dornier singleflex laser fibers are fragile and must be handled with utmost care.Avoid bending or coiling fiber beyond the manufacturer recommended minimum bend radius (reference fiber specifications); doing so may result in light leakage or fiber breakage that could cause personal injury if laser is fired." qsf-670 rev c.
Event or Problem Description
Customer complained a holmium fiber broke within the channel of the ureteroscope.

• 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: 9158348
• Report Number: 1037955-2019-00041
• Device Sequence Number: 11427226
• Product Code: GEX
• UDI-Device Identifier: 00810116020348
• UDI-Public: 01008101160203481724070210F2619S
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2019

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: 07/02/2024
• Device Model Number: DORNIER SINGLEFLEX 200
• Device Catalogue Number: HOL200S
• Device Lot Number: F2619S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Device Age: 2 MO
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1