• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 03/16/2018
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: the event unit was not returned to applied medical for evaluation. In the absence of the subject device, it is difficult to determine the root cause of the event. 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.
 
Event Description
Procedure performed: "tamis transanal polyp excision" event description: "while passing an instrument through the trocar, the plastic piece came lose from the gelpoint path trocar and fell into the rectum then needing to be retrieved. Product was not being used in patient at the time of the event. There were no materials left in the patient. " additional information was received via email from advanced procedural implementation specialist on thursday march 22, 2018: "the color of the piece dislodged was clear and the surgeons removed it quickly with a grasper. There was not a need to get a new device. It ended up working just fine to remove the polyp, so no need for us to replace device. " additional information was received via email from advanced procedural implementation specialist on tuesday march 27, 2018: the facility discarded the unit. Type of intervention: "there were no materials left in the patient. The surgeons removed it quickly with a grasper. There was not a need to get a new device. " patient status: no patient injury. No permanent impairment of a body function or permanent damage to a body structure. No medical or surgical intervention necessary to preclude permanent impairment of a body function or permanent damage to a body structure. "no change".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
9497138059
MDR Report Key7440353
MDR Text Key106389842
Report Number2027111-2018-00116
Device Sequence Number1
Product Code FER
UDI-Device Identifier00607915124755
UDI-Public(01)00607915124755(17)200809(30)01(10)1301832
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
Report Date 04/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/09/2020
Device Model NumberCNO11
Device Catalogue Number101424301
Device Lot Number1301832
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 Received03/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

-
-