MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-10-20 for STRATOS 5500 manufactured by A.m. Surgical, Inc..
[4968077]
Blade fell off during cubital procedure and fell into wound. Blade was fished out. A new assembly was used and the procedure was finished without incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2437731-2014-00002 |
| MDR Report Key | 4195298 |
| Report Source | 99 |
| Date Received | 2014-10-20 |
| Date of Report | 2014-10-13 |
| Date of Event | 2014-09-02 |
| Date Mfgr Received | 2014-09-02 |
| Device Manufacturer Date | 2014-06-01 |
| 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 | 1. Required No Informationntervention | 2014-10-20 |