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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES G-8650, 86MM INSERT S/F 15/BX DXC

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APPLIED MEDICAL RESOURCES G-8650, 86MM INSERT S/F 15/BX DXC Back to Search Results
Model Number 15
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/24/2017
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 procedure), a medical staff tried to clamp a vessel, the insert g8650 was come off the clamp. This event didn't affect the patient. Additional information received via email from distributor april 5, 2017 - the insert was able to be retrieved from the patient. No damage occured to the vessel. According to the sales rep, the surgeon used fogarty hydragrip clamp by edwards lifesciences corporation. The clamp model could not be identified. 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 event was improper technique during installation of the insert, as this can cause damage to the attachment features of the insert and make it unable to remain attached to the clamp. The instructions for use (ifu) states, "to place inserts, open the clamp to spread both clamp jaws. Place the button located on the proximal end of the insert into the mounting hole. Snap the other button into the clamp by pressing forward and down on the insert with firm hand pressure. Do not press down directly on this button. " 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-8650, 86MM 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 Key6513688
MDR Text Key73460944
Report Number2027111-2017-01731
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
PMA/PMN Number
15
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 Model Number15
Device Catalogue Number15
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
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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