MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-17 for ENTACT SEPTAL STAPLER, 1-PACK 601-00100S manufactured by Arthrocare Corp..
[80299993]
Patient Sequence No: 1, Text Type: N, H10
[80299994]
It was reported that when the stapler was squeezed, it cracked and all the pieces came out. It is unknown whether any of the pieces fell into the surgical site or were left in situ. It was also noted that a s&n back-up device was not available so the method/device(s) used to complete the procedure is unknown. No patient injury or other complications have been reported.
Patient Sequence No: 1, Text Type: D, B5
[115822000]
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. More than likely, upon squeezing with unintended excessive force of the device trigger this caused the handle to be become dismantled? Fall apart?. 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 | 3006524618-2017-00184 |
| MDR Report Key | 6719259 |
| Date Received | 2017-07-17 |
| Date of Report | 2017-09-27 |
| Date of Event | 2017-06-20 |
| Date Mfgr Received | 2017-09-22 |
| Date Added to Maude | 2017-07-17 |
| 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 | 0 |
| Brand Name | ENTACT SEPTAL STAPLER, 1-PACK |
| Generic Name | SEPTAL STAPLER/ABSORBABLE STAPLES |
| Product Code | OLL |
| Date Received | 2017-07-17 |
| Catalog Number | 601-00100S |
| Lot Number | 409054 |
| 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 | 2017-07-17 |