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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 CNO11
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/10/2016
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
Tamis - "transparent instrument protector fell into rectal space during procedure. Instruments used was 10mm 30dg, attraumatic grasper and minopolar diathermy needle electrode. Both angled tem instruments. We discussed the happening after surgery where we concluded that the needle electrode may be the cause of incident. The device is taken care of at the department for pickup. No life threatening situation occured and the instrument protector was easy detected and removed from space. " patient status - "no life threatening situation occured".
 
Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation along with a dislodged instrument shield, an inner component of one of the trocars. Upon investigation, engineering observed scratch marks on the instrument shield, indicating that it had come into contact with an instrument. The root cause of the damage to the instrument shield is contact with an angled instrument. Applied medical's instructions for use (ifu) states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers. All instruments should be centered axially when inserted through the seal to prevent tearing. " applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary. 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, then 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
9497138059
MDR Report Key6174386
MDR Text Key62380612
Report Number2027111-2016-00885
Device Sequence Number1
Product Code FER
Combination Product (y/n)N
Reporter Country CodeNO
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
Report Date 12/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/30/2017
Device Model NumberCNO11
Device Catalogue Number101351501
Device Lot Number1235809
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/14/2016 Patient Sequence Number: 1
Treatment
10MM 30DG, ATTRAUMATIC GRASPER; MINOPOLAR DIATHERMY NEEDLE ELECTRODE
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