MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-13 for COUNTER BALANCE KERATOMETER 1204 manufactured by Marco Ophthalmic Inc..
[2436776]
Marco ophthalmic 1290 encore stands accessory arm - counter balanced keratometer arm model 1204 - have the potential for pinching the electrical wiring causing sparks near patients. The mfr has stated that this issue is not covered in warranty repair because the open wire has been caused by a pinch and not due to a mfg flaw. The wire rests in the joint of the arm where the pinching takes place in normal operation of the arm itself.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5024268 |
| MDR Report Key | 2462537 |
| Date Received | 2012-02-13 |
| Date of Report | 2012-02-13 |
| Date of Event | 2012-02-09 |
| Date Added to Maude | 2012-02-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COUNTER BALANCE KERATOMETER |
| Generic Name | COUNTER BALANCE KERATOMETER |
| Product Code | HJB |
| Date Received | 2012-02-13 |
| Model Number | 1204 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MARCO OPHTHALMIC INC. |
| Manufacturer Address | JACKSONVILLE FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-13 |