MAUDE Adverse Event Report: DORNIER MEDTECH AMERICA, INC. DORNIER MEDTECH; POWERED LASER SURGICAL INSTRUMENT

Model Number	200 SERIES SINGLE USE
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Plugged the fiber into the holmium laser and the laser would not read the fiber.

• Brand Name: DORNIER MEDTECH
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): DORNIER MEDTECH AMERICA, INC.; 1155 roberts boulevard; kennesaw GA 30144
• MDR Report Key: 7450596
• Report Number: 7450596
• Device Sequence Number: 107294
• Product Code: GEX
• UDI-Device Identifier: 00810116020218
• UDI-Public: (01)00810116020218
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2018
• Report Date (Section F): 04/09/2018

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: Physician
• Device Expiration Date: 11/01/2022
• Device Model Number: 200 SERIES SINGLE USE
• Device Catalogue Number: HLFDS200C
• Device Lot Number: F4317S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HOLMIUM LASER
• Patient Age: 24 YR
• Patient Weight: 90
• Date Report Sent to FDA: 04/09/2018