MAST QUADRANT RETRACTOR SYSTEM
Received Mar 29, 2012
Report 1030489-2012-00375 · MDR key 2509236
Device
Generic name
Light, Surgical, Carrier
Manufacturer
Warsaw Orthopedic, Inc.Model number
9560658Catalog number
9560658
Lot number
0174721W
Product problems
- Overheating of Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT "DURING AN UNKNOWN PROCEDURE, THE LIGHT SOURCE OVERHEATED, STOPPED WORKING, AND HAD A SMOKY SMELL." NO PATIENT COMPLICATIONS WERE REPORTED.
Additional Manufacturer Narrative
(B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative
ANALYSIS OF THE RETURNED DEVICE SHOWS THAT NO PRE-EXISTING DEFECT HAS BEEN IDENTIFIED ON THE RETURNED ITEM THAT CAN BE RESPONSIBLE OF THE EVENT. THE INSTRUCTION FOR USE OF THE DEVICE STATES: ''THE RECOMMENDED LIGHT SOURCE UTILIZES 100W LIGHT SOURCES AND 5MM FIBER 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. REDUCE INTENSITY LEVELS ON HIGH WATT LIGHT SOURCES/LARGE LIGHT CABLES AND TAKE PRECAUTIONS TO PROTECT PATIENT AND STAFF FROM INJURY.'' THE OVERHEATING AND THE DAMAGE OF THE DEVICE AS DESCRIBED IN THE EVENT MAY COME FROM THE USE OF INAPPROPRIATE CABLES AND/OR WATTAGE LIGHT SOURCE.