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

Model Number	K2013151
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint information was received for a holmium fiber which was identified to have broke inside the patient during operation.No reports of injury or patient complication were reported to dornier medtech america due to this product complaint.This complaint was initially reported to fda under 1037955-2020-00036 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: 11541910
• Report Number: 9611812-2021-00009
• Device Sequence Number: 17189115
• Product Code: GEX
• UDI-Device Identifier: 04049958003158
• UDI-Public: 01040499580031581724060310F2
• 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): 03/22/2021
• Report Date (Section F): 09/02/2020

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: 06/03/2024
• Device Model Number: K2013151
• Device Catalogue Number: K2013151
• Device Lot Number: F2219R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/06/2020
• Event Location: Other
• Date Report to Manufacturer: 09/02/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2021
• 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: 09/02/2020