MAUDE Adverse Event Report: PROPPER MFG. CO., INC. PROPPER MAC 3 OPTIC LARYNSCOPE BLADE; LARYNGOSCOPE, RIGID

Model Number 19914500

Device Problems Peeled/Delaminated (1454); Sharp Edges (4013)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/30/2023

Event Type  malfunction  

Event Description

Sterile processing brought us a mac 3 fiber optic laryngoscope blades and showed us that the outer coating is peeling off.They even stated that the tech that was processing it cut her hand on the sharp edges.We immediately checked our inventory and pulled everyone that we could find.Upon further inspection, they were all showing the same wear.Sterile processing has not changed any chemicals or procedures for processing the blades.The blades were ordered from the sharn medical catalog.They were ordered some time last year.

• Brand Name: PROPPER MAC 3 OPTIC LARYNSCOPE BLADE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): PROPPER MFG. CO., INC.
• MDR Report Key: 16683941
• MDR Text Key: 312936118
• Report Number: MW5116349
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 19914500
• Device Catalogue Number: 19914500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1