MAUDE Adverse Event Report: DORNIER MEDTECH AMERICA DORNIER HOLMIUM LASER FIBER

Model Number HOLMIUM LASER FIBER

Device Problem No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Event Description

It was reported that the holmium fiber was burned and charred.

Manufacturer Narrative

No sample was received for evaluation.Records indicate the product was manufactured in accordance with all specifications and requirements.

• Brand Name: DORNIER HOLMIUM LASER FIBER
• Type of Device: LASER FIBER
• Manufacturer (Section D): DORNIER MEDTECH AMERICA; 1155 roberts blvd; suite 100; kennesaw GA 30144
• Manufacturer (Section G): DORNIER MED TECH AMERICA; 1155 roberts blvd; suite 100; kennesaw GA 30144
• Manufacturer Contact: john hoffer ; 1155 roberts blvd; suite 100; kennesaw, GA 30144 ; 7705146163
• MDR Report Key: 18478404
• MDR Text Key: 333090963
• Report Number: 1037955-2023-00060
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/25/2023

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: HOLMIUM LASER FIBER
• Device Catalogue Number: K2013151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/25/2023
• Initial Date FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 68 KG