MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-10-10 for ENTACT SEPTAL STAPLER 601-00100 manufactured by Entrigue Surgical, Inc..
[3034456]
The physician endoscopically conducted a nasal septoplasty surgery on (b)(6) 2012. The entact septal stapler is supplied pre-loaded with eight resorbable staple implants. Using the entact septal stapler, all eight implants were placed into the mucosal tissue on both sides of the pt's septum for coaptation. According to the physician, a visual verification (via endoscope) was performed upon implantation of the resorbable implants and successful insertion of all eight staples was confirmed. There were no delays or issues with the entact septal stapler during the surgery. The pt was released after the surgery without any issues. The pt returned to the clinic several days post-op with nasal obstruction. According to the physician, the pt experienced a septal hematoma that required an incision to drain the hematoma and a needle/syringe was used to drain the hematoma. According to the physician, no further complications have been observed during subsequent post-operative visits and the pt has recovered normally.
Patient Sequence No: 1, Text Type: D, B5
[10194555]
The entrigue surgical sales representative ((b)(4)) reported on (b)(4) 2012 that an adverse event occurred following a case with dr (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007134070-2012-00003 |
| MDR Report Key | 2785745 |
| Report Source | 05,07 |
| Date Received | 2012-10-10 |
| Date of Report | 2012-09-13 |
| Date of Event | 2012-08-30 |
| Date Mfgr Received | 2012-09-13 |
| Device Manufacturer Date | 2012-05-01 |
| Date Added to Maude | 2012-10-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 12672 SILICON DRIVE SUITE 150 |
| Manufacturer City | SAN ANTONIO TX 78249 |
| Manufacturer Country | US |
| Manufacturer Postal | 78249 |
| Manufacturer Phone | 2102986398 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTACT SEPTAL STAPLER |
| Generic Name | SEPTAL STAPLER / ABSORBABLE STAPLES |
| Product Code | OLL |
| Date Received | 2012-10-10 |
| Catalog Number | 601-00100 |
| Lot Number | 205018 |
| Device Expiration Date | 2014-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENTRIGUE SURGICAL, INC. |
| Manufacturer Address | 12672 SILICON DRIVE STE 150 SAN ANTONIO TX 78249 US 78249 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-10-10 |