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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH DISPOLED DISP FO LARYNGOSCOPE HANDLE; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH DISPOLED DISP FO LARYNGOSCOPE HANDLE; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 77700
Device Problems Overheating of Device (1437); Battery Problem (2885)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/18/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer reported after opening the device and putting a blade on, the customer experienced "significant heat" and "the battery exploded inside of handle." no user or patient harm reported.
 
Manufacturer Narrative
Qn#(b)(4).The sample was returned by the customer and forwarded on to the manufacturer in china (honfield).Honfield reports they "opened the package and found only 'shell' and 'cap' were included, but missed the inner part (like the batteries insert , led housing etc )".It was also reported in the investigation that "hf could not provide details investigation analysis since we do not have the whole complaint product.Also hf never find this kind of issue in the assembly process.".
 
Event Description
Customer reported after opening the device and putting a blade on, the customer experienced "significant heat" and "the battery exploded inside of handle".No user or patient harm reported.
 
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Brand Name
RUSCH DISPOLED DISP FO LARYNGOSCOPE HANDLE
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key9566016
MDR Text Key189498222
Report Number3011137372-2020-00012
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,foreig
Type of Report Initial,Followup
Report Date 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date05/27/2022
Device Catalogue Number77700
Device Lot Number1905011
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2020
Date Manufacturer Received02/18/2020
Patient Sequence Number1
Treatment
POLARIS BLADE; POLARIS BLADE
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