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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. CARR-LOCKE INJECTION NEEDLE

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UNITED STATES ENDOSCOPY GROUP, INC. CARR-LOCKE INJECTION NEEDLE Back to Search Results
Model Number 00711811
Device Problems Retraction Problem (1536); Insufficient Information (3190)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/25/2021
Event Type  malfunction  
Manufacturer Narrative
The device subject of the event will be returned to steris endoscopy for evaluation. The device history record was reviewed and confirmed the device lot was manufactured to specification. Statements in the instructions for use include: "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. Do not attempt to actuate the injection needle with the catheter in a straightened position. The injection needle has been engineered and manufactured with a specific "preload" that is necessary to assure the full projection and full retraction of the needle from the distal hub when the device is in very tortuous configurations. " steris endoscopy has offered in-service training on the use of the carr-lock injection needle to the user facility; however, the user facility has declined. A follow-up mdr will be submitted when additional information becomes available. No additional issues have been reported.
 
Event Description
The user facility reported via health (b)(6) report to steris that their carr-locke injection needle failed to retract. There was no report of harm to the patient or user of the device.
 
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Brand NameCARR-LOCKE INJECTION NEEDLE
Type of DeviceINJECTION NEEDLE
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 Key13258267
MDR Text Key286049184
Report Number1528319-2022-00003
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
971842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 01/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number00711811
Device Catalogue Number00711811
Device Lot Number2100298
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received12/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/15/2021
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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