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

Model Number	HOL200S
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	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The identified fiber was not available for evaluation from the complaint facility.No indications were revealed in this investigation that the identified production lot was not manufactured in accordance to applicable dornier specifications and operated as intended prior to release by production personnel.It can be confirmed each holmium fiber is subject to visual defect and performance (power testing) evaluation prior to release for distribution.The distal tip of each holmium fiber unit is magnified and verified for acceptable standard and each unit is affixed around the applicable bend test fixture to ensure flexibility is within specification.This complaint is unable to be confirmed as no unit was obtainable for evaluation and this investigation did not reveal deviations associated with the identified production lot, hol200s lot f2619s.It is acknowledged holmium fibers are fragile and must be handled with utmost care as indicated in the applicable holmium fiber instruction for use, qsf-670.The complaint was reported to dmta quality first via medwatch report mw5089801 on 8 october 2019.The territory assigned sales representative was contacted regarding the event which occurred (b)(6) 2019.It was identified the responsible representative did not forward complaint details to quality upon her receipt of the complaint 9 september 2019.A capa was initiated in response to this identification.
Event or Problem Description
Complainant reported a laser fiber broke.

• 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: 9274068
• Report Number: 1037955-2019-00050
• Device Sequence Number: 150803
• Product Code: GEX
• UDI-Device Identifier: 00810116020348
• UDI-Public: 01008101160203481724070210F2619S
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K152591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• 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: HOL200S
• Device Lot Number: F2619S
• Was Device Available for Evaluation?: No
• Device Age: 4 MO
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1