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

Catalog Number 004411100

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem Insufficient Information (4580)

Event Date 12/15/2021

Event Type  malfunction  

Event Description

There is a need for confirmation on the following aspects of the instruction for use details for greenspec fiberoptic blade and handle systems: specific bulb holder assembly and bulb cleaning/disinfection instructions.These instructions should also address whether enzymatic/germicidal spray on the product after the point of use is safe for the greenspec fiberoptic blade and handle systems.The ifu refers to ¿moist wipe" but more detail is needed on the validation of use of common operative antimicrobial wipes on greenspec fiberoptic blade and handle systems, and whether, per aami/iscahm best practices, the system can be pre-treated with an enzymatic solution.Instructions on handle assembly that included specifics on the bulb holder assembly and the friction piece.Specifics on handling/reassembly of the greenspec fiberoptic blade and handle systems if the friction piece has become dislodged.Specifics on cleaning and disinfecting for all bulb types (including replacement bulbs) for this system.Specifics on how automated washers and sterilization systems are validated and what needs to be in place to use automated cleaning.This should also include whether the bulb holder assembly can be safely cleaned with an automated washer.While the one version of the ifu states a ¿european automated washer¿, more detail is needed.Clarification on which sterrad machine is best to use with greenspec fiberoptic blade and handle systems.(note: there are no sterrad 100 machines available.).Confirmation on the applicability of iso7376 to the specific incandescent and fiber optic systems of greenspec fiberoptic blade and handle systems.

• Brand Name: RUSCH GREENSPEC
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 13167907
• MDR Text Key: 283244778
• Report Number: 13167907
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2021

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 Catalogue Number: 004411100
• Device Lot Number: 200801
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1