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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DORNIER MEDTECH AMERICA DORNIER HOLMIUM LASER FIBER
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DORNIER MEDTECH AMERICA DORNIER HOLMIUM LASER FIBER Back to Search Results
Model Number K2013062
Medical Device Problem Codes Fracture (1260); No Apparent Adverse Event (3189)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Event or Problem Description
A notification was received regarding a holmium fiber which was reported to have burned.No patient harm was reported.This complaint was initially reported to fda under 1037955-2020-00038 on (b)(6) 2020.
 
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Brand Name
DORNIER HOLMIUM LASER FIBER
Common Device Name
HOLMIUM LASER FIBER
Manufacturer (Section D)
DORNIER MEDTECH AMERICA
1155 roberts blvd. n.w.
kennesaw GA 30144
MDR Report Key11548816
Report Number9611812-2021-00010
Device Sequence Number19816565
Product Code GEX
UDI-Device Identifier04049958003097
UDI-Public01040499580030971724110110F4419S
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Importer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/23/2021
Report Date (Section F) 09/09/2020
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 Date11/01/2024
Device Model NumberK2013062
Device Catalogue NumberK2013062
Device Lot NumberF4419S
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date09/09/2020
Event Location Other
Date Report to Manufacturer09/09/2020
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/23/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Date Report Sent to FDA09/09/2020
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