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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNO11, GELPOINT PATH 5.5CM FER

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APPLIED MEDICAL RESOURCES CNO11, GELPOINT PATH 5.5CM FER Back to Search Results
Model Number CNO11
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/02/2016
Event Type  malfunction  
Manufacturer Narrative
No product is being returned for evaluation but lot # is provided. A device history report is to be reviewed by engineering. A follow-up report will be sent once the results have been analyzed. 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
"the inner black seal out of the trocar came away and was found inside the cannula whilst in the patient. The trocar was equally spaced from one another and not too close to the outer ring. The entire seal popped out. The reason was because the surgeon used a 'swap on a stick', to clean and wipe the seal of blood so the camera wouldn't get dirty on reintroduction, and inadvertently pushed too deep and pushed the black seal out. " intervention - "it was retrieved safely. " patient status - "fine. ".
 
Manufacturer Narrative
The event unit was not returned to applied medical for evaluation. Based on the description of the complainant's experience, the seal dislodgement was caused by the surgeon when a swab on a stick was used to clean the internal seal. The swab was inadvertently pushed too deep into the trocar and pushed the seal out. This could occur if the swab was inserted at an angle instead of axially. The instructions for use (ifu) states that "all instruments should be centered axially when inserted through the seal. " 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 NameCNO11, GELPOINT PATH 5.5CM
Type of DeviceFER
Manufacturer (Section D)
APPLIED MEDICAL RESOURCES
22872 avenida empresa
rancho santa margarita CA 92688
Manufacturer Contact
22872 avenida empresa
rancho santa margarita, CA 92688
9497138233
MDR Report Key5989418
MDR Text Key55998988
Report Number2027111-2016-00624
Device Sequence Number1
Product Code FER
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K133393
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 03/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/14/2019
Device Model NumberCNO11
Device Catalogue Number101424301
Device Lot Number1268347
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 Received09/02/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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