FDA Adverse Event
Malfunction
Summary report: N
MAST QUADRANT RETRACTOR SYSTEM
MDR report key: 1070061
·
Received July 3, 2008
Report
- Report Number
- 1030489-2008-00308
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- May 23, 2008
- Report Date
- June 6, 2008
- Manufacturer
- WARSAW ORTHOPEDIC INC.
- Product Code
- FSZ
- PMA / PMN Number
- K043602
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LIGHT CABLE WAS RETURNED TO MEDTRONIC FOR EVALUATION. A VISUAL EXAMINATION OF THE CABLE CONFIRMS HIGH TEMPS PRESENT AT THE LIGHT SOURCE ATTACHMENT END. THIS SUGGESTS THE USE OF A MACHINE WITH GREATER THAN THE 100W INSTRUCTED ON THE PACKAGING. PACKAGE LABELING INDICATES THAT THE RECOMMENDED LIGHT SOURCE UTILIZES 100W LIGHT SOURCES AND 5MM OPTIC CABLES. USE OF LARGER CABLES AND/OR HIGHER WATTAGE LIGHT SOURCES MAY RESULT IN HIGH TEMPERATURES ON THE METAL CONNECTION TO THE LIGHT CABLE, WHICH MAY RESULT IN INJURY TO PATIENT OR STAFF AND DAMAGE TO PRODUCT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SURGERY WHILE USING THE ILLUMINATION SYSTEM, THE CABLE MELTED, CREATING SMOKE/HEAT AND WOULD NOT FUNCTION PROPERLY. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAST QUADRANT RETRACTOR SYSTEM | ILLUMINATION SYSTEM | FSZ | WARSAW ORTHOPEDIC INC. | NA | W08B1264 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |