MAUDE Adverse Event Report: DORNIER MEDTECH AMERICA, INC. DORNIER HOLMIUM LASER FIBER

Model Number	DORNIER SINGLEFLEX 400
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the returned device by dornier manufacturing manager and dornier quality engineer determined the device was operating within dornier specifications.No defects were noted with the device as manufactured.No fault was identified with the device during this investigation and the device was confirmed to be performing as intended.It is acknowledged the device was returned with the black boot dislodged from the blue laser fiber connector and that the customer may have interpreted this as a breakage of the fiber, although the fiber was not broken.The cause of the dislocation of the black boot was unable to be determined.It can be confirmed each holmium laser fiber is 100% inspected for both visual and performance inconsistencies prior to release for distribution.
Event or Problem Description
Customer complained a holmium fiber arrived "already broken".

• Brand Name: DORNIER HOLMIUM LASER FIBER
• Common Device Name: HOLMIUM LASER FIBER
• Manufacturer (Section D): DORNIER MEDTECH AMERICA, INC.; 1155 roberts blvd; suite 100; kennesaw 30144
• MDR Report Key: 9130962
• Report Number: 1037955-2019-00042
• Device Sequence Number: 19465130
• Product Code: GEX
• UDI-Device Identifier: 00810116020362
• UDI-Public: 01008101160203621724071810B2819S
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K123385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2019

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: Other
• Device Expiration Date: 07/18/2024
• Device Model Number: DORNIER SINGLEFLEX 400
• Device Catalogue Number: HOL400S
• Device Lot Number: B2819S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1