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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC REX 6.9FR URETEROSCOPE, 33CM URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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GYRUS ACMI, INC REX 6.9FR URETEROSCOPE, 33CM URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number REXMR-6A
Device Problem Sharp Edges (4013)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/28/2022
Event Type  malfunction  
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Brand NameREX 6.9FR URETEROSCOPE, 33CM
Type of DeviceURETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
GYRUS ACMI, INC
93 north pleasant st.
norwalk OH 44857
Manufacturer Contact
todd brill
93 north pleasant st.
norwalk, OH 44857
5082077661
MDR Report Key15107042
Report Number1519132-2022-00009
Device Sequence Number1
Product Code FGB
UDI-Device Identifier00821925007826
UDI-Public00821925007826
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052044
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 08/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberREXMR-6A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2022
Was the Report Sent to FDA? No
Date Manufacturer Received07/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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