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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 Problems Detachment Of Device Component (1104); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/09/2016
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.
 
Event Description
Ta tme, practicing purse-string during ta tme workshop in lap-trainer in human colon- "during the purse-string exercise for ta tme at the ta tme workshop at (b)(6) center the delegate and faculty member spotted the plastic ring in the human colon ( in the lap-trainer) when they pulled the camera back. The plastic ring came out of the trocar that was used for a hand-instrument. The trocar has not been used for the scope. " patient status: n/a.
 
Manufacturer Narrative
Investigation summary: one (1) 10mm trocar sleeve was returned for evaluation. Upon visual inspection, engineering confirmed that the shield was fully dislodged from the seal of the trocar. Upon further inspection, engineering disassembled the 10mm sleeve and found that the septum and duckbill were torn. Two tears were found near the bottom opening of the septum and one tear was found on the bottom edge of the duckbill. All gelpoint® minis undergo 100% visual inspection during the assembly and packaging process. The most likely root cause of the shield dislodging would be inserting an instrument non-axially into the sleeve. There is always a potential to tear or dislodge the internal seal components with multiple passes of instruments, especially with sharp or angular devices. The instructions for use (ifu) warns "extra care should be used when inserting angular and asymmetrical instruments. To minimize eversion of the sleeve's seal, instruments with high textured surfaces should be coated with a sterile lubricant. " although the root cause of the event could not be confirmed, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary. Additional information requested and received. In accordance to 21 cfr 803. 56, if we obtain additional information, which was not known or was not available when this report was submitted, then the supplemental report will be submitted to the fda.
 
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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
wendy kobayashi
22872 avenida empresa
rancho santa margarita, CA 92688
9497138059
MDR Report Key5777499
MDR Text Key49029953
Report Number2027111-2016-00515
Device Sequence Number1
Product Code FER
Combination Product (y/n)N
Reporter Country CodeGB
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,Followup,Followup
Report Date 06/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/02/2019
Device Model NumberCNO11
Device Catalogue Number101424301
Device Lot Number1265864
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2016
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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