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 2019-04-16 for CNB10, GELPOINT PATH WITH ISB, 4CM UNKNOWN manufactured by Applied Medical Resources.
[142181553]
The event unit will not return to applied medical. A follow-up report will be provided upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[142181554]
Name of procedure being performed: transanal total mesorectal excision. Detailed description of event: [name] spoke with dr. [name] at the society for american gastrointestinal and endoscopic surgeons (sages). He shared feedback on the new gelpoint path models and detailed a case using cnb10 that caused patient injury. After completing a tatme on a small female, dr. [name] removed the platform and noticed a tear in the mucosa of the anal canal. He sutured the tear immediately and believes it was caused by the channel being too wide for the patient. The timeline for this occurrence is uncertain as it was reported to an applied team member at a surgical congress. The unit will not be returned. Concomitant device: ni. Patient status: stable, injury corrected at time of event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2019-00424 |
| MDR Report Key | 8520657 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-16 |
| Date of Report | 2019-06-06 |
| Date Mfgr Received | 2019-04-04 |
| Date Added to Maude | 2019-04-16 |
| 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 | CNB10, GELPOINT PATH WITH ISB, 4CM |
| Generic Name | FER |
| Product Code | FER |
| Date Received | 2019-04-16 |
| Model Number | CNB10 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| 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 EMPRSA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-16 |