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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENSPEC FO HANDLE MEDIU; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH GREENSPEC FO HANDLE MEDIU; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 004411100
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/01/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer complaint alleges "there is a small washer below the light bulb that wears off during sterilization.This in turn causes the handle to get dangerously hot when batteries are inserted." (continued) alleged issue reported as detected prior to a patient use.No patient injury or consequence was reported.Patient condition reported as fine.No user injury reported.
 
Event Description
Customer complaint alleges "there is a small washer below the light bulb that wears off during sterilization.This in turn causes the handle to get dangerously hot when batteries are inserted." (continued) alleged issue reported as detected prior to a patient use.No patient injury or consequence was reported.Patient condition reported as fine.No user injury reported.
 
Manufacturer Narrative
(b)(4).One (1) 004411100 greenspec fiber optic handle, medium, was received for investigation.Upon receipt the handle was visual examined for any signs of abuse/misuse/damage.Further inspection inside the light chamber of the handle has uncovered a missing insulator which could contribute to the handle heating.The ifu for this product states, "the batteries and bulb chamber in greenspec, snap-light, and emerald must be removed prior to cleaning/disinfection/sterilization." the bulb chamber incorporates two green insulators.One insulator is located near the bulb itself, recessed in the bulb chamber, the other insulator is press fitted into a more conspicuous location on the bottom of the bulb chamber.These easily seen insulators serve two purposes.First, they are electrical insulators preventing a grounding or "shorting" condition as the battery current travels from the battery casing to the bulb itself.And secondly, they serve as "guides" for the electrical pin connector.The bottom insulator fits against the cap of the battery and guides the contact pin which makes contact directly on top of the battery.If that insulator is missing the contact pin could make contact with the body of the handle which in turn would create a "short" condition.The short condition would drain the battery current to the metal housing causing it to heat to hazardous temperatures.Age can be a factor in the insulator deterioration and eventual destruction, and so can frequent and incorrectly administered sterilization and disi nfection processes.Once the insulator material begins to break down it does not take long for it to disintegrate.While a definitive root cause cannot be assigned to the insulator deterioration, the missing insulator is the catalyst for the handle heating.The co mplaint has been confirmed, but a definitive root cause cannot be assigned.
 
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Brand Name
RUSCH GREENSPEC FO HANDLE MEDIU
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key8482394
MDR Text Key140896412
Report Number8030121-2019-00026
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 04/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number004411100
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2019
Date Manufacturer Received04/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BATTERIES (MANUFACTURER UNKNOWN).; BATTERIES (MANUFACTURER UNKNOWN).; BATTERIES (MANUFACTURER UNKNOWN).
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