MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-26 for SYNERGETICS 23 G DIRECTIONAL LASER PROBE 55.26.23 manufactured by Synergetics.
[17097188]
Laser probe was not recognized by laser machine. Another probe had to be opened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2478625 |
| MDR Report Key | 2478625 |
| Date Received | 2012-02-26 |
| Date of Report | 2012-02-24 |
| Date of Event | 2012-01-09 |
| Report Date | 2012-02-24 |
| Date Reported to FDA | 2012-02-26 |
| Date Added to Maude | 2012-03-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNERGETICS 23 G DIRECTIONAL LASER PROBE |
| Generic Name | SYNERGETICS 23 G DIRECTIONAL LASER PROBE |
| Product Code | HQB |
| Date Received | 2012-02-26 |
| Returned To Mfg | 2012-02-06 |
| Model Number | NA |
| Catalog Number | 55.26.23 |
| Lot Number | 1060122; 04/2014 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGETICS |
| Manufacturer Address | 3845 CORPORATE CENTRE DR O FALLON MO 63368 US 63368 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-26 |