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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH MRI SET: HANDLE+ MIL 0,1 MAC 2,3,4; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH MRI SET: HANDLE+ MIL 0,1 MAC 2,3,4; LARYNGOSCOPE, RIGID Back to Search Results
Model Number IPN915573
Device Problem Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/05/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that: "during the first use, we observed that 3 batteries out of 4 that are in the kit were not working.The blades have light only with 1 of the batteries.No light with the other 3 batteries".No patient involvement reported.
 
Manufacturer Narrative
Qn#(b)(4).The sample was returned and sent to the manufacturing site for investigation.The device history record of lot 161102 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The manufacturing site reports "during investigation it is identify that battery cartridges has found out of warranty period & had exceeded the self-life of 18 months at the time of complaint reported.".
 
Event Description
It was reported that: "during the first use, we observed that 3 batteries out of 4 that are in the kit were not working.The blades have light only with 1 of the batteries.No light with the other 3 batteries".No patient involvement reported.
 
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Brand Name
RUSCH MRI SET: HANDLE+ MIL 0,1 MAC 2,3,4
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key11859058
MDR Text Key251804414
Report Number8030121-2021-00020
Device Sequence Number1
Product Code CCW
UDI-Device Identifier14026704712530
UDI-Public14026704712530
Combination Product (y/n)N
PMA/PMN Number
K062523
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 05/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date01/06/2022
Device Model NumberIPN915573
Device Catalogue Number5442M
Device Lot Number161201
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2021
Date Manufacturer Received06/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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