MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-29 for ENTACT SEPTAL STAPLER, 3-PACK 601-00100 manufactured by Arthrocare Corp..
[49160390]
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Patient Sequence No: 1, Text Type: N, H10
[49160391]
It was reported that during a procedure using the entact septal stapler, the doctor alleged that the staples would not seat in the mucosa. The doctor opted to complete the procedure using a backup device. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[50920976]
The device was tested and upon squeezing of the trigger using a test pad, a staple was deployed as intended; therefore, the device performed as intended. The complaint could not be verified as the returned device performed as intended. The root cause could not be determined with confidence as several factors could contribute to the reported event. It is possible that an attempt was made to staple thick or hard tissue, placing the staple at the edge of cartilage, or an attempt to staple tissue in a constrained anatomical area which prevents the stapler arms from opening completely. The instructions for use for the device contains warning and precautionary measures regarding use of the device. A review of the manufacturing records for the device found no deficiencies associated with the alleged event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006524618-2016-00154 |
| MDR Report Key | 5759954 |
| Date Received | 2016-06-29 |
| Date of Report | 2016-06-16 |
| Date of Event | 2016-06-16 |
| Date Mfgr Received | 2016-06-16 |
| Date Added to Maude | 2016-06-29 |
| 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 | JIM GONZALES |
| Manufacturer Street | 7000 W WILLIAM CANNON |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer G1 | ARTHROCARE CORP. |
| Manufacturer Street | 7000 W. WILLIAM CANNON |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78735 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTACT SEPTAL STAPLER, 3-PACK |
| Generic Name | SPLINT, INTRANASAL SEPTAL |
| Product Code | LYA |
| Date Received | 2016-06-29 |
| Returned To Mfg | 2016-06-23 |
| Catalog Number | 601-00100 |
| Lot Number | 501039 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROCARE CORP. |
| Manufacturer Address | 7000 W. WILLIAM CANNON AUSTIN TX 78735 US 78735 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-29 |