FDA Adverse Event
Malfunction
Summary report: N
TISSUE TEK VIP6 TISSUE PROCESSOR
MDR report key: 1732348
·
Received June 16, 2010
Report
- Report Number
- 2083544-2010-00001
- Event Type
- Malfunction
- Date Received
- June 16, 2010
- Date of Event
- February 24, 2010
- Report Date
- March 24, 2010
- Manufacturer
- SAKURA SEIKI CO. LTD.
- Product Code
- IEO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
VALVE MODIFICATION HAS BEEN UNDERTAKEN. THE MANUFACTURE OF THE IMPROVED VALVES IS IN PROGRESS. EXPECTED DELIVERY IS TO BEGIN IN (B)(4) 2010, AND FIELD IMPLEMENTATION TO BEGIN UPON DELIVERY. MODIFIED INSTRUMENTS WILL BE MONITORED TO ENSURE EFFECTIVENESS OF THE DESIGN CHANGES.
Description of Event or Problem · 1
DURING NORMAL FUNCTION WHEN ATTEMPTING TO ROTATE THE ROTATING VALVES THE INSTRUMENT SENSES FAILURE TO ROTATE VALVES. THE INSTRUMENT AUTOMATICALLY RETRIES THE MOVEMENT AND GENERATES ERROR CODES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TISSUE TEK VIP6 TISSUE PROCESSOR | VIP6 | IEO | SAKURA SEIKI CO. LTD. | 6030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |