MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-11 for DISPOSABLE HIGH SPEED CUTTER 23G/8000CPM 8267.VIT23 manufactured by D.o.r.c. Dutch Ophthalmic Research Center (interna.
[133336273]
Air came out from the nose of the probe 8267. Vit23 with lot: 2000396702, which we unpacked during the surgery. We tried two more probes with the same lot number, yet we had the same problem. The surgery was completed with another vitrectomy probe with a different lot number. Investigation can be started as soon as devices will be received.
Patient Sequence No: 1, Text Type: N, H10
[133336274]
Air came out from the nose of the probe 8267. Vit23 with lot: 2000396702, which we unpacked during the surgery. We tried two more probes with the same lot number, yet we had the same problem. The surgery was completed with another vitrectomy probe with a different lot number.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222074-2019-00005 |
| MDR Report Key | 8239483 |
| Date Received | 2019-01-11 |
| Date Added to Maude | 2019-01-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CHRIS FRYER |
| Manufacturer Street | SCHEIJDELVEQEG 2 |
| Manufacturer City | ZUILAND, NETHERLANDS 3214VN |
| Manufacturer Country | NL |
| Manufacturer Postal | 3214 VN |
| Manufacturer G1 | D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA |
| Manufacturer Street | SCHEIJDELVEQEG 2 |
| Manufacturer City | ZUILAND, NETHERLANDS 3214VN |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 3214 VN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DISPOSABLE HIGH SPEED CUTTER 23G/8000CPM |
| Generic Name | OPHTHALMIC SURGICAL INSTRUMENT HANDLE, PNEUMATIC |
| Product Code | MLZ |
| Date Received | 2019-01-11 |
| Model Number | 8267.VIT23 |
| Catalog Number | 8267.VIT23 |
| Lot Number | 2000396702 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA |
| Manufacturer Address | SCHEIJDELVEQEG 2 ZUILAND, NETHERLANDS 3214VN NL 3214 VN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-11 |