MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-08 for DIRECTIONAL LASER PROBE 55.36.25E manufactured by Synergetics Usa, Inc..
[74915347]
Faulty laser probe broke during vitrectomy case. Fragment of probe was recovered from pt's eye. Add'l probe was used in case without complication. No apparent harm to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069659 |
| MDR Report Key | 6556886 |
| Date Received | 2017-05-08 |
| Date of Report | 2017-05-05 |
| Date of Event | 2017-05-02 |
| Date Added to Maude | 2017-05-10 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIRECTIONAL LASER PROBE |
| Generic Name | LASER |
| Product Code | HQB |
| Date Received | 2017-05-08 |
| Returned To Mfg | 2017-05-02 |
| Model Number | 55.36.25E |
| Lot Number | M429120 |
| Device Expiration Date | 2017-12-31 |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGETICS USA, INC. |
| Manufacturer Address | 3845 CORPORATE CENTRE DRIVE O'FALLON MO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-08 |