MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-09 for PUNCH D9.00MM 17200D900 manufactured by Moria.
[5672968]
Patient was having a penetrating keratoplasty procedure done. The donor cornea was being prepared on the back table. The surgeon and scrub tech were using the moria punch d9. 00mm, (b)(4), lot 1141905 to cut the cornea. After cutting the cornea, the syringe on the punch was pushed and the cornea flew off of the donor punch. The surgeon, scrub tech, circulator and crna all tried to locate the cornea but were unable to find it. No incision on the patient was made. No adverse affect to patient. The case was cancelled by surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042079 |
| MDR Report Key | 4692492 |
| Date Received | 2015-04-09 |
| Date of Report | 2015-04-09 |
| Date of Event | 2015-04-08 |
| Date Added to Maude | 2015-04-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| 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 |
| Generic Name | PUNCH D9.00MM |
| Product Code | HNJ |
| Date Received | 2015-04-09 |
| Model Number | PUNCH D9.00MM |
| Catalog Number | 17200D900 |
| Lot Number | 1141905 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MORIA |
| Manufacturer Address | ANTONY 92160 FR 92160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-09 |