FDA Adverse Event
Malfunction
Summary report: N
KAUFMAN VITRECTOR III
MDR report key: 172286
·
Received June 15, 1998
Report
- Report Number
- 1045254-1998-00005
- Event Type
- Malfunction
- Date Received
- June 15, 1998
- Date of Event
- June 5, 1998
- Report Date
- June 15, 1998
- Manufacturer
- XOMED SURGICAL PRODUCTS, INC.
- Product Code
- HKP
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KAUFMAN VITRECTOR III | VITRECTOMY KIT | HKP | XOMED SURGICAL PRODUCTS, INC. | NA | 14145800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |