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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRUPHATEK INTERNATIONAL LTD. RUSCH MRI COND FIBER OPTIC LARYN KIT; LARYNGOSCOPE, RIGID
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TRUPHATEK INTERNATIONAL LTD. RUSCH MRI COND FIBER OPTIC LARYN KIT; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 005852300
Device Problems Electrical /Electronic Property Problem (1198); Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/12/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device involved in this complaint has not been received by the manufacturer at the time of this report.The investigation into this complaint is still in progress.
 
Event Description
Customer complaint alleges "in their mri conditional kit, the miller 1 blade does not work.Upon looking at the blade, it seems to be missing a part that allows electrical current to the handle.Customer stated that they had not used this blade until just recently and came to them this way." alleged issue reported as detected during pre-testing, prior to patient use.There was no report of patient impact or consequence.
 
Event Description
Customer complaint alleges "in their mri conditional kit, the miller 1 blade does not work.Upon looking at the blade, it seems to be missing a part that allows electrical current to the handle.Customer stated that they had not used this blade until just recently and came to them this way." alleged issue reported as detected during pre-testing, prior to patient use.There was no report of patient impact or consequence.
 
Manufacturer Narrative
(b)(4).One mri conditional fiber optic kit was received for investigation.All blades, the handle, and the spare batteries were returned.Upon visual inspection the missing isolated contact post was confirmed as missing.The missing connector post could have dislodged for any number of reasons.This contact point experiences a lot of activity in that each time the blade is engaged to a handle the contact point will experience the pressure of blade engagement.If unnecessary pressure is applied to the blade in engagement then the contact point experiences unnecessary wear.The complaint has been confirmed and root cause is undetermined with the understanding that unusual or rough handling could have contributed to this failure.A conclusion code could not be found as the complaint was confirmed; however, a root cause was not established.
 
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Brand Name
RUSCH MRI COND FIBER OPTIC LARYN KIT
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TRUPHATEK INTERNATIONAL LTD.
netanya
MDR Report Key7486936
MDR Text Key107353932
Report Number8030121-2018-00043
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 04/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number005852300
Device Lot Number1429016704
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2018
Date Manufacturer Received05/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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