MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-03 for MICROSURGICAL INSTRUMENT, 23GA. SOFT TIP NEEDLE manufactured by Alconmedical Safety.
[21656121]
Pt having a 23 gauge pars plana vitrectomy, right eye. Upon placing a 23g soft tip needle into a 23g cannula into the patient's eye, the surgeon noticed that the silicone soft tip was missing from the needle. The surgeon thoroughly searched the eye and surroundings. The silicone soft tip was found on the outside of the eye. No harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030817 |
| MDR Report Key | 3216143 |
| Date Received | 2013-07-03 |
| Date of Report | 2013-07-03 |
| Date of Event | 2013-06-12 |
| Date Added to Maude | 2013-07-11 |
| 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 | RISK MANAGER |
| 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 |
| Brand Name | MICROSURGICAL INSTRUMENT, 23GA. SOFT TIP NEEDLE |
| Generic Name | SOFT TIP NEEDLE |
| Product Code | HNM |
| Date Received | 2013-07-03 |
| Lot Number | 925997M |
| ID Number | REF 8065149523 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCONMEDICAL SAFETY |
| Manufacturer Address | 6201 SOUTH FREEWAY MAIL CODE AB2-6 FORT WORTH TX 76134200 US 76134 2001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-07-03 |