MAUDE Adverse Event Report: MYCO MEDICAL GLASS VAN; CARBON STEEL STERILE SURGICAL BLADE #15

Model Number 2001T-15

Device Problem Degraded (1153)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/27/2023

Event Type  malfunction  

Event Description

Knife blades appeared rusted when opened during set up.Blades were not used on patients.

• Brand Name: GLASS VAN
• Type of Device: CARBON STEEL STERILE SURGICAL BLADE #15
• Manufacturer (Section D): MYCO MEDICAL; 2015 production drive; apex NC 27539
• Manufacturer (Section G): MYCO MEDICAL; 2015 production drive; apex NC 27539
• Manufacturer Contact: tim krotchko ; 2015 production drive; apex, NC 27539 ; 9194602535
• MDR Report Key: 18372686
• MDR Text Key: 331373349
• Report Number: 3014527682-2023-00022
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/21/2023

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 Model Number: 2001T-15
• Device Catalogue Number: 2001T-15
• Device Lot Number: 230202AC
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/21/2023
• 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: Initial
• Patient Sequence Number: 1