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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. ARTICULATOR INJECTION NEEDLE

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UNITED STATES ENDOSCOPY GROUP, INC. ARTICULATOR INJECTION NEEDLE Back to Search Results
Model Number 00711807
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/13/2022
Event Type  malfunction  
Manufacturer Narrative
The device subject of the event was not returned for evaluation as the user facility discarded the device. Without the returned device the root cause of the reported event cannot be determined. The injection needles information for use states, "carefully remove the tip protector from the distal tip of the needle. Actuate the proximal luer back and forth, visually observing the needle being adequately advanced from the device's distal end. The spring-loaded handle assists in needle retraction; however, always visually check the retraction as well. Note: do not stretch the device because stretching may cause the needle projection length to be altered. To lock the needle in the out position, gently press the proximal luer until it meets the handle's luer, and then slowly twist the proximal luer clockwise until the two luers are fully engaged. Ensure that the needle is fully retracted prior to inserting it into the endoscope. To unlock the needle, slowly twist the proximal luer counterclockwise until the two luers disengage. " the device history record was reviewed, and no abnormalities were identified. A three-year complaint review for this lot indicates this to be an isolated occurrence. No additional issues were noted.
 
Event Description
The user facility reported via vigilance report that during a patient procedure which included use of an injection needle the device would not withdraw the needle. Another injection needle was utilized to complete the procedure. No report of patient harm.
 
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Brand NameARTICULATOR INJECTION NEEDLE
Type of DeviceNEEDLE
Manufacturer (Section D)
UNITED STATES ENDOSCOPY GROUP, INC.
5976 heisley road
mentor OH 44060
Manufacturer (Section G)
UNITED STATES ENDOSCOPY GROUP, INC.
5976 heisley road
mentor OH 44060
Manufacturer Contact
coletta cohara
5976 heisley road
mentor, OH 44060
4403586251
MDR Report Key14242104
MDR Text Key290463016
Report Number1528319-2022-00023
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number00711807
Device Catalogue Number00711807
Device Lot Number2110642
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/04/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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