MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. LOADING CAR; LOADING CAR TO 60" CENTURY STERILIZER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived on-site to inspect the sterilizer and loading car.No issues were identified, and no repairs or adjustments were made.The sterilizer and loading car were returned to service.The technician further discussed the reported injury with user facility personnel who disclosed that while removing the loading car from the sterilizer, the loading car went off its track.The employee lifted the loading car back onto the track, at which point he felt a "pop" in his forearm.He then visited employee healthcare; however, no treatment was administered.The employee returned to work the same day.The loading car came off the track as the transfer carriage being used to remove the loading car from the sterilizer was not properly aligned with the sterilizer by the user facility employee.While on-site the technician counseled user facility personnel on the proper use and operation of the sterilizer and loading car, with focus on loading and unloading practices.The operator manual states (pp.1-1), "get help if loading car becomes stuck or difficult to move.Do not attempt to lift a loading car without assistance." no additional issues have been reported.

Event Description

The user facility reported an employee was injured while removing a loading car from their sterilizer.

• Brand Name: LOADING CAR
• Type of Device: LOADING CAR TO 60" CENTURY STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 7894234
• MDR Text Key: 121450376
• Report Number: 3005899764-2018-00091
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1