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

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".

• Brand Name: CNO11, GELPOINT PATH 5.5CM
• Type of Device: FER
• 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 Key: 7440353
• MDR Text Key: 106389842
• Report Number: 2027111-2018-00116
• Device Sequence Number: 1
• Product Code: FER
• UDI-Device Identifier: 00607915124755
• UDI-Public: (01)00607915124755(17)200809(30)01(10)1301832
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2020
• Device Model Number: CNO11
• Device Catalogue Number: 101424301
• Device Lot Number: 1301832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1