MAUDE Adverse Event Report: OPTICAL INTEGRITY KLF-001-600 .6MM FIBER; INNOVOYCE LASER FIBER

Model Number	KLF-001-600
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device investigation is completed.It was observed that there was a mechanical break at the distal tip of the fiber.The area of breakage indicated a longitudinal force was applied to the tip.It is suspected that device was mishandled by the user.Per device ifu, under the "precaution" section, it is stated "do not bend fiber at sharp angles." and "care should be exercised with the glass tip to avoid severe impacts or side stresses which may fracture the tip." please note, this is innovoyce's first electronic report, and it was delayed due to issues with the esg portal signing certificate verification process.Fda's mdr policy was notified.
Event or Problem Description
Innovoyce received a customer report of a product problem with the.600 ktp fiber, where the fiber "broke off inside a patient" during a routine procedure.The physician retrieved the piece of fiber from the patient and the patient was intubated as a precaution.There was no patient harm.

• Brand Name: KLF-001-600 .6MM FIBER
• Common Device Name: INNOVOYCE LASER FIBER
• Manufacturer (Section D): OPTICAL INTEGRITY; 19408 panama city beach prkwy; panama city beach FL 32413
• Manufacturer (Section G): OPTICAL INTEGRITY; 19408 panama city beach prkwy; panama city beach FL 32413
• Manufacturer Contact: stephen mais ; one beacon st. floor 15th; boston, MA 02108 ; 2034176140
• MDR Report Key: 17083624
• Report Number: 3024753061-2023-00001
• Device Sequence Number: 12323252
• Product Code: GEX
• UDI-Device Identifier: 00860004755913
• UDI-Public: (01)00860004755913
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K022338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/07/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: KLF-001-600
• Device Catalogue Number: KLF-001-600
• Device Lot Number: M19806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female