MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-04-18 for CNO11, GELPOINT PATH 5.5CM 101424301 manufactured by Applied Medical Resources.
[106389842]
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.
Patient Sequence No: 1, Text Type: N, H10
[106389843]
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".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2018-00116 |
| MDR Report Key | 7440353 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-18 |
| Date of Report | 2018-04-18 |
| Date of Event | 2018-03-16 |
| Date Mfgr Received | 2018-03-20 |
| Device Manufacturer Date | 2017-08-01 |
| Date Added to Maude | 2018-04-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138059 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CNO11, GELPOINT PATH 5.5CM |
| Generic Name | FER |
| Product Code | FER |
| Date Received | 2018-04-18 |
| Model Number | CNO11 |
| Catalog Number | 101424301 |
| Lot Number | 1301832 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-18 |