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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNO12, GELPOINT PATH 9CM FER

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APPLIED MEDICAL RESOURCES CNO12, GELPOINT PATH 9CM FER Back to Search Results
Model Number CNO12
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/12/2016
Event Type  malfunction  
Manufacturer Narrative
The incident device is anticipated to return. A follow-up report will be provided upon completion of investigation. In accordance to 21 cfr 803. 56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda. There is no report of serious injury or death associated with this event.
 
Event Description
"during procedure the sealguard (clear plastic internal piece) detached and was pushed through cannula causing loss of pneumo. Instruments being used were angled graspers, angled 10mm 45 degree scope, angle point cautery, straight graspers and suction-irrigation. No harm to patient. " patient status: "no harm to patient. ".
 
Manufacturer Narrative
The event unit was not returned for evaluation. In the absence of the subject device, it is difficult to determine the root cause. The most likely root cause of the trocar shield dislodgement is the insertion of an angular or bent instrument. The instructions for use (ifu), warns that "extra care should be used when inserting angular and asymmetrical instruments. " all instruments should be centered axially when inserted through the shield to prevent dislodgement. 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. In accordance to 21 cfr 803. 56, if additional information is obtained which was not known or was not available when this report was submitted, a supplemental report will be submitted to the fda.
 
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Brand NameCNO12, GELPOINT PATH 9CM
Type of DeviceFER
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
9497138000
MDR Report Key6018828
MDR Text Key57053127
Report Number2027111-2016-00640
Device Sequence Number1
Product Code FER
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/15/2019
Device Model NumberCNO12
Device Catalogue Number101192201
Device Lot Number1276321
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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