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

Model Number	K2013062
Medical Device Problem Codes	Connection Problem (2900); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the returned device by dornier quality engineer determined the device was burnt at the connector end rendering the fiber inoperable.The charring of the fiber was noted predominately on one side of the fiber which is characteristic of a misaligned laser.The complainant stated the reported fiber burn was noted "after surgery".The unit was found with the fiber connector nearly entirely disconnected.The duration of use and state of the laser last used with this holmium fiber was not confirmed.It is acknowledged the single use holmium fiber was able to be utilized for the duration of a case, and the burn was noted following surgery.It can be confirmed each holmium laser fiber is 100% inspected for both visual and power testing performance defects prior to release for distribution.
Event or Problem Description
Complaint details provided in the initial notification stated, "fiber burnt at connector end.This was observed by ut nurse after surgery.".

• 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: 9238314
• Report Number: 1037955-2019-00052
• Device Sequence Number: 13492893
• Product Code: GEX
• UDI-Device Identifier: 04049958002632
• UDI-Public: 01040499580026321723121910F5118S
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K123385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2019

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: 12/19/2023
• Device Model Number: K2013062
• Device Lot Number: F5118S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Device Age: 10 MO
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1