MAUDE Adverse Event Report: MEDSOURCE LABS, LLC. CURAPLEX; LED LARYNGOSCOPE BLADE AND HANDLE

Model Number	301-F0-MIL-3-S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that "the item fell apart".
Additional Manufacturer Narrative
The back portion of the laryngoscope blade which connects to the handle appears to have broken.

• Brand Name: CURAPLEX
• Common Device Name: LED LARYNGOSCOPE BLADE AND HANDLE
• Manufacturer (Section D): MEDSOURCE LABS, LLC.; 8600 shelby ct.; suite 100; chanhassen MN 55317
• Manufacturer Contact: asad hayat ; hayat center; khadim all road sialkot; punjab, 51310 ; PK 51310
• MDR Report Key: 20238309
• Report Number: 3003674698-2024-00817
• Device Sequence Number: 15582701
• Product Code: CCW
• UDI-Device Identifier: 00812277038194
• UDI-Public: 00812277038194
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2024

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: 301-F0-MIL-3-S
• Device Catalogue Number: 301-FO-MIL-3-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown