MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2012-03-15 for CARB-EDGE IRIS SCS 4-1/2 STR 101300 manufactured by Integra York, Pa Inc..
[18251016]
Medwatch # (b)(4). "small tip of an iris scissors was broken off away from incision site while doctor was attempting to tighten a screw on an adson beckman retractor. The field and floor searched, but to no avail. X-ray taken and read as negative by doctor. A small piece of metal was found on the floor after x-ray was taken, resembling missing piece. Unable to determine if it was the actual piece. " per the reporter "the doctor used the iris scissors to tighten the screw on the retractor. "
Patient Sequence No: 1, Text Type: D, B5
[18521109]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2012-00025 |
| MDR Report Key | 2549741 |
| Report Source | 00,06 |
| Date Received | 2012-03-15 |
| Date of Report | 2012-03-15 |
| Date of Event | 2012-03-02 |
| Date Mfgr Received | 2012-03-12 |
| Date Added to Maude | 2012-08-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CAREN FERNANDEZ |
| Manufacturer Street | 315 ENTERPRISE DR. |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARB-EDGE IRIS SCS 4-1/2 STR |
| Generic Name | NA |
| Product Code | FTN |
| Date Received | 2012-03-15 |
| Catalog Number | 101300 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-15 |