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

Model Number HOL270S

Device Problem Fracture (1260)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 07/12/2022

Event Type  malfunction  

Manufacturer Narrative

The unit returned was verified as a representative sample from the identified production lot.No process deviations or manufacturing defects were revealed upon review of the device records and evaluation of the returned device.It is acknowledged all holmium fibers are 100% power tested and visually inspected prior to release which confirms the operational capacity and state of the fiber.It is acknowledged the likely root cause was related to the handling of the laser fiber device.It is possible the laser fiber was broken after removal from the protective packaging which when engaged with the laser device caused a total fiber breakage.Without access to the actual suspect device, this cannot be confirmed.Dornier laser fibers are fragile and must be handled with care as instructed on the dornier laser fiber ifu.

Event Description

A laser fiber was reported to have broken during usage, causing a superficial burn to the technician.No follow up or treatement was determined to be mandatory due to the superficial burn.No further impact was reported to dmta as a result of the complaint as reported.

• Brand Name: DORNIER HOLMIUM LASER FIBER
• Type of Device: HOLMIUM LASER FIBER
• Manufacturer (Section D): DORNIER MEDTECH AMERICA, INC.; 1155 roberts blvd; suite 100; kennesaw GA 30144
• Manufacturer (Section G): DORNIER MEDTECH AMERICA, INC.; 1155 roberts blvd; suite 100; kennesaw GA 30144
• Manufacturer Contact: amber stallings ; 1155 roberts blvd; suite 100; kennesaw, GA 30144 ; 7705146204
• MDR Report Key: 15245613
• MDR Text Key: 298244851
• Report Number: 1037955-2022-00036
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00810111602035
• UDI-Public: 010081011160203551727011010F0122S
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2022

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
• Device Model Number: HOL270S
• Device Lot Number: F0122S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1