FDA Adverse Event Other Summary report: N

ATLAS 60" TRANSFER CARRIAGE

MDR report key: 1277403 · Received November 11, 2008

Report

Report Number
2515984-2008-00014
Event Type
Other
Date Received
November 11, 2008
Date of Event
September 25, 2008
Report Date
November 11, 2008
Manufacturer
STERIS MEXICO S. DE R.L. DE C.V.
Product Code
FLE
PMA / PMN Number
NA
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
NO INFORMATION

Narratives

Additional Manufacturer Narrative · 1

A STERIS TECHNICIAN VISITED THE HOSPITAL AND EXAMINED THE TRANSFER CART. THE CART WAS IN GOOD CONDITION AND DID NOT REQUIRE REPAIR. THE INSTRUMENT TRAY HAD NO SHARP EDGES, BUT WAS AN OLDER MODEL THAT HAD ROOM BETWEEN THE TRAY HANDLE AND THE MOUNTING BLOCK. THE HOSPITAL STAFF REPORTED THAT THE TRANSFER CART BECAME STUCK AND IT WAS PUSHED FROM THE SIDE RATHER THAN FROM THE TOP AS RECOMMENDED, RESULTING IN THE INSTRUMENT TRAY SHIFTING POSITION ON THE CART. IN THE PROCESS, THE EMPLOYEE'S FINGER SLIPPED BETWEEN THE HANDLE OF THE INSTRUMENT TRAY HANDLE AND THE MOUNTING BLOCK AND THEN STRUCK THE POST OF THE TRANSFER CART, RESULTING IN A CUT OF THE OPERATOR'S FINGER.

Description of Event or Problem · 1

THE USER FACILITY REPORTS THE EMPLOYEE IS NO LONGER WORKING FOR THE FACILITY BUT IS WORKING FOR ANOTHER HOSPITAL AND IS PERFORMING THE SAME JOB DUTIES.

Description of Event or Problem · 1

AN OPERATOR CUT HER FINGER WHILE MOVING LOADED INSTRUMENT TRAYS FROM ATLAS TRANSFER CART INTO A STEAM STERILIZER. THE TRANSFER CART IS USED TO MOVE INSTRUMENT TRAYS TO AND FROM WASHING AND STERILIZATION EQUIPMENT. IT WAS REPORTED THAT THE OPERATOR WENT TO THE HOSPITAL'S EMERGENCY ROOM FOR TREATMENT OF THE CUT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ATLAS 60" TRANSFER CARRIAGE TRANSFER CARRIAGE FLE STERIS MEXICO S. DE R.L. DE C.V. 4011084 NA

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention