MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-14 for ROSEN CHOPPER UNK manufactured by Katena Products Inc..
[54749624]
The subject device was not returned for evaluation nor was the specific device item number reported. Subject device named in the received motion did not identify specific product id numbers. Based on this, the subject device could be one of two katena devices or even a competitor's device with the "rosen" name. The two subject "rosen" devices have been in commercial distribution, by this manufacturer, since november 1993 & february 1995 respectively. A review of katena's rosen device manufacturing processes and quality control methods confirmed, no anomalies or changes that could adversely affect device safety or effectiveness. Examination of two representative sample rosen devices did not find any abnormalities that could cause product failure as reported. Review of manufacturers complaint handling system database no other adverse reportable events for this subject device.
Patient Sequence No: 1, Text Type: N, H10
[54749625]
Report of legal motion indicates post cataract surgery on (b)(6) 2016 a 1mm metal flake was observed in sub-incisional iris. Patient required an mri for other medical issues and there was concern for the metal flake in the iris. Based on this, subsequent surgical intervention, to remove foreign body, was performed but, not successful in that the metal fragment was firmly adherent to the iris and surgeon was concerned forcible removal could disinsert the iris. Surgeon reported he did not believe this foreign body would be a risk for movement during an mri and that removal would involve cutting iris tissue, which he did not think was justified given the low risk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242450-2016-00002 |
| MDR Report Key | 5951186 |
| Date Received | 2016-09-14 |
| Date of Report | 2016-09-15 |
| Date of Event | 2012-08-20 |
| Date Mfgr Received | 2016-08-15 |
| Date Added to Maude | 2016-09-14 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR BRYAN WEINMANN |
| Manufacturer Street | 4 STEWART COURT |
| Manufacturer City | DENVILLE NJ 07834 |
| Manufacturer Country | US |
| Manufacturer Postal | 07834 |
| Manufacturer Phone | 9739891600 |
| Manufacturer G1 | KATENA PRODUCTS INC |
| Manufacturer Street | 4 STEWART COURT |
| Manufacturer City | DENVILLE NJ 07834 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07834 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ROSEN CHOPPER |
| Generic Name | OPHTHALMIC SPATULA |
| Product Code | HNQ |
| Date Received | 2016-09-14 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KATENA PRODUCTS INC. |
| Manufacturer Address | 4 STEWART COURT DENVILLE 07834 US 07834 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-09-14 |