MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-09-27 for ENTACT SEPTAL STAPLER, 3-PACK 601-00100 manufactured by Arthrocare Corp..
[55740891]
.
Patient Sequence No: 1, Text Type: N, H10
[55740892]
It was reported that several weeks following a procedure using an entact septal stapler, the surgeon noticed pinpoint perforations in the patient's septum. The surgeon feels the pinpoint perforations are not healing as they should. No details were provided regarding any post operative treatment administered.
Patient Sequence No: 1, Text Type: D, B5
[58280568]
Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation. Thus, the complaint could not be verified and a root cause could not be determined with confidence. Factors not associated with the manufacture or design of the device which may have contributed to the reported event include preexisting conditions that could compromise and/or affect healing of the surgical site, or possibly inadvertently firing the empty device which will cause the implant guide needle to pierce and make a hole in the septum. The instructions for use (ifu) for the device contains warning and precautionary measures regarding use of the device. No lot number was provided; hence a review of manufacturing records could not be completed. However, there are no indications that would suggest that the device did not meet product specifications upon release into distribution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006524618-2016-00257 |
| MDR Report Key | 5980510 |
| Report Source | USER FACILITY |
| Date Received | 2016-09-27 |
| Date of Report | 2016-10-24 |
| Date of Event | 2016-08-30 |
| Date Mfgr Received | 2016-08-30 |
| Date Added to Maude | 2016-09-27 |
| 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 DR. |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123585706 |
| 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 | SEPTAL STAPLER/ABSORBABLE STAPLES |
| Product Code | OLL |
| Date Received | 2016-09-27 |
| Catalog Number | 601-00100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Required No Informationntervention | 2016-09-27 |