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 2017-05-04 for CNO12, GELPOINT PATH 9CM 10 manufactured by Applied Medical Resources.
[74427798]
The event device is anticipated to return. A follow-up report will be provided upon completion of investigation. There is no report of serious injury or death associated with this event.
Patient Sequence No: 1, Text Type: N, H10
[74427799]
Transanal mass incision - the seal from the gelpoint trocar sleeve was dislodged towards the end of the case. A storz needle driver and vlock suture were used within the sleeve. It was stated that the instruments were passed through the sleeve no more than 10 times and the manipulation of the instruments were not considered aggressive. The surgeon was able to retrieve the piece with no patient injury. Type of intervention - na. Patient status - no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2017-01764 |
| MDR Report Key | 6544520 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-05-04 |
| Date of Report | 2017-12-05 |
| Date of Event | 2017-04-19 |
| Date Mfgr Received | 2017-04-19 |
| Device Manufacturer Date | 2015-09-01 |
| Date Added to Maude | 2017-05-04 |
| 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 | 9497138059 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CNO12, GELPOINT PATH 9CM |
| Generic Name | FER |
| Product Code | FER |
| Date Received | 2017-05-04 |
| Returned To Mfg | 2017-05-02 |
| Model Number | 10 |
| Catalog Number | 10 |
| Lot Number | 1253551 |
| Device Expiration Date | 2018-09-02 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-05-04 |