MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-06 for CATARACT INSTRUMENT SET UNK manufactured by .
[49281919]
Cataract surgical instrument set: surgeon reported a high degree of product variability when the same instruments were compared from add'l cataract instruments sets from the same vendor to include inconsistent sizes of the instruments, different angles to each conner wand, and questionable integrity of the seibel chopper. The finish on the instruments appeared rough under the microscope and not conductive to use on delicate, thin membranes of the eye. These instruments were considered by the surgeon and supported by add'l surgeons observations. On (b)(6) 2016, the cataract instrument set was opened for a case, but never used due to being determined that the product was not safe for pt use per surgeon unk mfrs, however, some instruments in the set were etched with (b)(6) medical on them and some instruments were packed with (b)(6) medical name on them. Distributor: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063322 |
| MDR Report Key | 5781799 |
| Date Received | 2016-07-06 |
| Date of Report | 2016-07-06 |
| Date of Event | 2016-06-09 |
| Date Added to Maude | 2016-07-11 |
| 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 |
| 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 | CATARACT INSTRUMENT SET |
| Generic Name | CATARACT INSTRUMENT SET |
| Product Code | KYG |
| Date Received | 2016-07-06 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-06 |