MAUDE Adverse Event Report: DORNIER MEDTECH AMERICA DORNIER HOLMIUM LASER FIBER

Model Number	K2013062
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The 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 1037955-2020-00025 on (b)(6) 2020.

• 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 Key: 11502078
• Report Number: 9611812-2021-00008
• Device Sequence Number: 3829328
• Product Code: GEX
• UDI-Device Identifier: 04049958003097
• UDI-Public: 01040499580030971724090510F3819S
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• 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): 03/16/2021
• Report Date (Section F): 08/03/2020

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: 09/05/2024
• Device Model Number: K2013062
• Device Catalogue Number: K2013062
• Device Lot Number: F3819S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/15/2020
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 08/03/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/03/2020