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

Model Number	CNO12
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.".
Additional 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.

• Brand Name: CNO12, GELPOINT PATH 9CM
• Common Device Name: FER
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6018828
• Report Number: 2027111-2016-00640
• Device Sequence Number: 66441
• Product Code: FER
• UDI-Device Identifier: 00607915126742
• UDI-Public: (01)00607915126742(17)190815(30)01(10)1276321
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K133393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 08/15/2019
• Device Model Number: CNO12
• Device Catalogue Number: 101192201
• Device Lot Number: 1276321
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2016
• Supplement Date Received by Manufacturer: Not provided; 09/12/2016
• Initial Report FDA Received Date: 10/11/2016
• Supplement Report FDA Received Date: 02/22/2017; 12/05/2017
• Patient Sequence Number: 1