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

Model Number K2308084

Device Problems Material Fragmentation (1261); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A notification was received regarding 2 diode fiber units which were reported to have broken during usage.

Manufacturer Narrative

No units were returned for evaluation of this complaint as the customer reportedly disposed of the suspect devices.It is acknowledged all laser fibers are 100% power tested as well as visually inspected prior to release which confirms the operational capacity of the device.The root cause of the complaint as reported (distal tip breakage) was not able to be confirmed, however, it is likely to relate to a mechanical force placed on the unit or the method of application of the device.Confirmations from the complaint facility regarding the procedure completed or the outcome of the complaint reported were not received within the timeframe of this investigation despite follow up with the account to request information.Dornier will continue to monitor complaints related to this report.No trends related to the manufacturing of the device, process or material deviations, or batch defects were identified during investigation of the two production lots identified by the complainant.

• Brand Name: DORNIER DIODE LASER FIBER
• Type of Device: DIODE LASER FIBER
• Manufacturer (Section D): DORNIER MEDTECH AMERICA, INC.; 1155 roberts blvd; suite 100; kennesaw 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 ; 1105146204
• MDR Report Key: 15762036
• MDR Text Key: 303990207
• Report Number: 1037955-2022-00051
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/10/2022

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 Operator: Health Professional
• Device Model Number: K2308084
• Device Lot Number: C3122S, C4421S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/10/2022
• Initial Date FDA Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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