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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A3219, SHORT HANDLE, SZ 3-40 DEG CLAMP CLAMP, VASCULAR

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APPLIED MEDICAL RESOURCES A3219, SHORT HANDLE, SZ 3-40 DEG CLAMP CLAMP, VASCULAR Back to Search Results
Model Number A3219
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/31/2021
Event Type  malfunction  
Manufacturer Narrative
The incident device is anticipated to return. A follow-up report will be provided upon completion of investigation.
 
Event Description
Procedure performed: cags. [name] was scrubbed for the case one of the clamps that has the inserts that they put on the jaws. [name] applied the inserts to the jaws and did one click of the ratchet as she normally does and put it on her mayo. When she went to give it to the surgical team they noticed that the ratchet wasn¿t working. They looked at the box joint of the clamp and noticed a fracture through one of the arms. This same issue has happened in january with another 1 of 6 clamps that were purchased at the same time. Intervention: ni. Patient status: patient is fine, and completely unaffected.
 
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Brand NameA3219, SHORT HANDLE, SZ 3-40 DEG CLAMP
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
APPLIED MEDICAL RESOURCES
22872 avenida empresa
rancho santa margarita CA 92688
Manufacturer Contact
wendy kobayashi
22872 avenida empresa
rancho santa margarita, CA 92688
9497138059
MDR Report Key11642445
MDR Text Key250359175
Report Number2027111-2021-00440
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K950492
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA3219
Device Catalogue Number100607001
Device Lot Number1327756
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/14/2018
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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