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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH DISPOGRIP SU STD HANDLE; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH DISPOGRIP SU STD HANDLE; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 88800
Device Problem Optical Problem (3001)
Patient Problem No Patient Involvement (2645)
Event Date 11/03/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
Customer reported "the light flickers or goes out completely".The issue was detected prior to use on the patient.
 
Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
Customer reported "the light flickers or goes out completely".The issue was detected prior to use on the patient.
 
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Brand Name
RUSCH DISPOGRIP SU STD HANDLE
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key10870017
MDR Text Key217463822
Report Number3011137372-2020-00255
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 11/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date06/12/2022
Device Catalogue Number88800
Device Lot Number1906051
Was Device Available for Evaluation? No
Date Manufacturer Received12/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
RUSCH EQUIPLITE BLADE, MAC 3.; RUSCH EQUIPLITE BLADE, MAC 3.
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