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

Model Number	HLFDBX0600C
Medical Device Problem Codes	Fracture (1260); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the returned device by dornier quality engineer confirmed the device was broken before use as indicated by the complainant.No manufacturing defects were noted upon review of the device and the scan of the rfid tag confirmed the unit was operating as intended upon power testing by production personnel.It is acknowledged the unit was broken upon return to dornier for evaluation.The cause of the holmium fiber breakage can not be confirmed, however, holmium fibers are coiled into a protective sheath for protection of the device and an external force on the unit would be the only cause of a fiber breakage as observed.It is recognized the reported fiber is a 600 micron unit and due to its size is consequently more durable and less prone to breakage.It can be confirmed each holmium laser fiber is 100% inspected for both visual and performance inconsistencies prior to release for distribution, including verifications the specification for required bend radius can be sustained utilizing a bend test fixture.The complaint as reported was confirmed but it is likely the root cause of the fiber breakage related to external forces placed on the unit which caused an unintended breakage.Holmium fibers are fragile and must be handled with utmost care as indicated in the applicable holmium fiber instruction for use, qsf-474.
Event or Problem Description
Complainant reported a disposable laser fiber was found broken in the package.

• 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: 9238318
• Report Number: 1037955-2019-00054
• Device Sequence Number: 13485002
• Product Code: GEX
• UDI-Device Identifier: 00810116020027
• UDI-Public: 01008101160200271723100510C4018S
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/17/2019

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: 10/05/2023
• Device Model Number: HLFDBX0600C
• Device Lot Number: C4018S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Device Age: 12 MO
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1