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

Model Number	HOL200S
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Report was received (b)(6) 2019 dealing a laser fiber breakage identified at (b)(6) center in (b)(6).This complaint was initially reported to fda under (b)(4) on (b)(6) 2019.

• 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: 11434198
• Report Number: 9611812-2021-00002
• Device Sequence Number: 4014389
• Product Code: GEX
• UDI-Device Identifier: 00810116020348
• UDI-Public: 01008101160203481724070210F2619S
• 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): 03/08/2021
• Report Date (Section F): 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 Catalogue Number: HOL200S
• Device Lot Number: F2619S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/29/2019
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2021
• 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: 09/09/2019