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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES G-4550, 45MM INSERT S/F 15/BX DXC

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APPLIED MEDICAL RESOURCES G-4550, 45MM INSERT S/F 15/BX DXC Back to Search Results
Model Number 14
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/22/2017
Event Type  malfunction  
Manufacturer Narrative
Ra has received the incident device and the product has been assigned to engineering for evaluation. A follow-up report will be sent upon completion of the investigation.
 
Event Description
Event description: (on (b)(6) 2017, during a preparation): a medical staff tried to attach the insert g4550 to a clamp, however; it did not fit. Another package of insert was opened but the medical staff confirmed deformation at the button. Thus the medical staff canceled to use the second one. This event didn't affect the patient. Additional information received via email from distributor april 5, 2017 - the defects for the g-4550 were noticed before the procedure. Procedure performed: unknown. Type of intervention: na. Patient status: no health damage was reported for the patient.
 
Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation. Upon visual inspection, engineering determined that the male attachment features (buttons) of the insert were damaged, which would affect the unit's ability to attach to the clamp. It is likely that the root cause of the damage observed on the unit was caused by was improper technique during installation of the insert onto the assembly fixture during manufacturing. This can cause damage to the attachment features, as was observed on the event unit. Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary to ensure the performance and safety of its products.
 
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Brand NameG-4550, 45MM INSERT S/F 15/BX
Type of DeviceDXC
Manufacturer (Section D)
APPLIED MEDICAL RESOURCES
22872 avenida empresa
rancho santa margarita CA 92688
Manufacturer Contact
22872 avenida empresa
rancho santa margarita, CA 92688
9497133904
MDR Report Key6513685
MDR Text Key73461953
Report Number2027111-2017-01730
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
PMA/PMN Number
14
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/04/2018
Device Model Number14
Device Catalogue Number14
Device Lot Number1188662
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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