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 2016-10-11 for CNO12, GELPOINT PATH 9CM 101192201 manufactured by Applied Medical Resources.
[57053127]
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.
Patient Sequence No: 1, Text Type: N, H10
[57053128]
"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. "
Patient Sequence No: 1, Text Type: D, B5
[68622817]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027111-2016-00640 |
| MDR Report Key | 6018828 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-10-11 |
| Date of Report | 2017-12-01 |
| Date of Event | 2016-09-12 |
| Date Mfgr Received | 2016-09-12 |
| Device Manufacturer Date | 2016-08-01 |
| Date Added to Maude | 2016-10-11 |
| 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 Contact | WENDY KOBAYASHI |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CNO12, GELPOINT PATH 9CM |
| Generic Name | FER |
| Product Code | FER |
| Date Received | 2016-10-11 |
| Model Number | CNO12 |
| Catalog Number | 101192201 |
| Lot Number | 1276321 |
| Device Expiration Date | 2019-08-15 |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-10-11 |