MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-12 for SCRAPER MEMBRANE DIAMOND DUST 338.23 408632 manufactured by Synergetics Corp..
[49781321]
Retractable loop broke off inside the patient's eye. Broken piece retrieved intra-operatively without harm to the patient. Diagnosis or reason for use: vitrectomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063434 |
| MDR Report Key | 5797959 |
| Date Received | 2016-07-12 |
| Date of Report | 2016-07-12 |
| Date of Event | 2016-06-30 |
| Date Added to Maude | 2016-07-15 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SCRAPER MEMBRANE DIAMOND DUST |
| Generic Name | 23G CURVED MEMBRANE SCRAPER |
| Product Code | HRK |
| Date Received | 2016-07-12 |
| Model Number | 338.23 |
| Catalog Number | 408632 |
| Lot Number | F133240 |
| Device Expiration Date | 2018-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGETICS CORP. |
| Manufacturer Address | O'FALLON MO 63368 US 63368 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-12 |