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

Model Number	HOL270R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The two holmium fiber units identified by this complaint were not returned to dornier medtech within the timeframe of investigation and it was confirmed by the complainant 12 november 2020 the units were not going to be available.It is acknowledged each holmium laser fiber manufactured by dornier medtech america is 100% inspected for both visual and power testing performance defects prior to release for distribution.It is understood that holmium fibers are fragile, and must be handled with care, as instructed in the dornier medtech holmium fiber ifu.This investigation did not reveal any manufacturing defects, or process deviations, and it is recognized no other complaints involving broken units noted out of packaging have been received for hol270r lot f2620r.The facility storage procedure for dornier holmium fibers was not confirmed and the likelihood of two units being released for distribution inside packaging broken is very low due to multiple manufacturing process controls.
Event or Problem Description
Complaint information was received for 2 holmium fibers, which were identified broken out of the box prior to usage.No patient impact occurred due to this product complaint.

• 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: 10832215
• Report Number: 1037955-2020-00043
• Device Sequence Number: 19274423
• Product Code: GEX
• UDI-Device Identifier: 00810116020447
• UDI-Public: 01008101160204471725063010F2620R
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K123385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/15/2020

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: 06/30/2025
• Device Model Number: HOL270R
• Device Lot Number: F2620R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1