MAUDE Adverse Event Report: TELEFLEX INCORPORATED RUSCH GREENSPEC HANDLE: MEDIUM; LARYNGOSCOPE, RIGID

Catalog Number 004411100

Device Problems Corroded (1131); Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 08/22/2022

Event Type  malfunction  

Event Description

Following the manufacturer's ifus, some of the blades and handles are coming out of sterile processing with some rust.Also, the panel on the blade where the light is transmitted, there is evidence of warping on some of them, the lip and the end of the fiberoptic channel on some of the blades have become sharper, and noticeable wear and tear of connecting parts between blade and handle on processed blades.Providers are having to wrap gauze around the handles to avoid injury when using the device.

• Brand Name: RUSCH GREENSPEC HANDLE: MEDIUM
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 15310363
• MDR Text Key: 298785058
• Report Number: 15310363
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/22/2022

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 Catalogue Number: 004411100
• Device Lot Number: 200901 AND 200801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1