MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1998-06-15 for KAUFMAN VITRECTOR III 85-50960 manufactured by Xomed Surgical Products, Inc..
[19148722]
It was discovered during an internal validation that some vitrector iii cutting heads have cracks in the irrigation adapters. The crack, when present, causes excessive and obvious leaking of irrigation fluid which may prevent replacement of aspirated vitreous fluid with irrigation fluid during vitrectomy procedures. While xomed has rec'd no reports of irrigation problems or injury in the last 24 mos, risk assessment suggests a potential for eye injury exists.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-1998-00005 |
| MDR Report Key | 172286 |
| Report Source | 00 |
| Date Received | 1998-06-15 |
| Date of Report | 1998-06-15 |
| Date of Event | 1998-06-05 |
| Date Mfgr Received | 1998-06-05 |
| Device Manufacturer Date | 1997-10-01 |
| Date Added to Maude | 1998-06-16 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KAUFMAN VITRECTOR III |
| Generic Name | VITRECTOMY KIT |
| Product Code | HKP |
| Date Received | 1998-06-15 |
| Model Number | NA |
| Catalog Number | 85-50960 |
| Lot Number | 14145800 |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 167527 |
| Manufacturer | XOMED SURGICAL PRODUCTS, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR. NORTH JACKSONVILLE FL 32216 US |
| Baseline Brand Name | KAUFMAN VITRECTORIII |
| Baseline Generic Name | VITRECTOMY KIT |
| Baseline Model No | NA |
| Baseline Catalog No | 85-50960 |
| Baseline ID | NA |
| Baseline Device Family | VITRECTOMY KIT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K761353 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-06-15 |