MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-09-30 for CNO11, GELPOINT PATH 5.5CM 101424301 manufactured by Applied Medical Resources.
[55998988]
No product is being returned for evaluation but lot # is provided. A device history report is to be reviewed by engineering. A follow-up report will be sent once the results have been analyzed. 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
[55998989]
"the inner black seal out of the trocar came away and was found inside the cannula whilst in the patient. The trocar was equally spaced from one another and not too close to the outer ring. The entire seal popped out. The reason was because the surgeon used a 'swap on a stick', to clean and wipe the seal of blood so the camera wouldn't get dirty on reintroduction, and inadvertently pushed too deep and pushed the black seal out. " intervention - "it was retrieved safely. " patient status - "fine. "
Patient Sequence No: 1, Text Type: D, B5
[69414180]
The event unit was not returned to applied medical for evaluation. Based on the description of the complainant's experience, the seal dislodgement was caused by the surgeon when a swab on a stick was used to clean the internal seal. The swab was inadvertently pushed too deep into the trocar and pushed the seal out. This could occur if the swab was inserted at an angle instead of axially. The instructions for use (ifu) states that "all instruments should be centered axially when inserted through the seal. " 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
| Report Number | 2027111-2016-00624 |
| MDR Report Key | 5989418 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-09-30 |
| Date of Report | 2017-03-02 |
| Date of Event | 2016-09-02 |
| Date Mfgr Received | 2016-09-02 |
| Device Manufacturer Date | 2016-04-01 |
| Date Added to Maude | 2016-09-30 |
| 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 | 9497138233 |
| 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 | 2016-09-30 |
| Model Number | CNO11 |
| Catalog Number | 101424301 |
| Lot Number | 1268347 |
| Device Expiration Date | 2019-04-14 |
| 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 | 2016-09-30 |