MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-10-20 for STRATOS 5500 manufactured by A.m. Surgical, Inc..
[18729080]
While inserting scope into device, manipulated the device side to side and attempted to deploy blade. Blade popped off.
Patient Sequence No: 1, Text Type: D, B5
[18815824]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2437731-2014-00001 |
| MDR Report Key | 4195268 |
| Report Source | 07 |
| Date Received | 2014-10-20 |
| Date of Report | 2014-10-13 |
| Date of Event | 2014-08-05 |
| Date Mfgr Received | 2014-08-29 |
| Device Manufacturer Date | 2014-08-05 |
| Date Added to Maude | 2014-11-03 |
| 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 Contact | VINCENT PASCALE |
| Manufacturer Street | 290 EAST MAIN ST. SUITE 200 |
| Manufacturer City | SMITHTOWN NY 11787 |
| Manufacturer Country | US |
| Manufacturer Postal | 11787 |
| Manufacturer Phone | 6319799777 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRATOS |
| Generic Name | ENDOSCOPIC KNIFE |
| Product Code | EMF |
| Date Received | 2014-10-20 |
| Model Number | 5500 |
| Lot Number | 0614 |
| Device Expiration Date | 2014-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | A.M. SURGICAL, INC. |
| Manufacturer Address | SMITHTOWN NY 11787 US 11787 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-20 |