MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. TRANSFER CARRIAGE; TRANSFER CARRIAGE TO STERILIZER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/11/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The transfer carriage did not properly engage to their sterilizer thus causing the transfer carriage to slide backwards subsequently causing the transfer cart to fall forward.A steris account manager arrived onsite to inspect the transfer carriage.The steris account manager inspected the transfer carriage and found the equipment to be operating properly.The account manager was unable to duplicate the reported event.The reported event may be attributed to user facility personnel not properly locking the transfer carriage to the sterilizer for removal of instruments.The operator manual states (pp.3-2), "align transfer carriage with rails inside sterilizer chamber and push transfer carriage toward sterilizer until front latches are engaged in end-frame slots."always positively latch loading car to transfer carriage when car is outside sterilizer." "disengage front latches by pulling front latch release knob and pull transfer carriage from sterilizer." the account manager discussed the proper use and operation of the transfer carriage with user facility personnel.

Event Description

The user facility reported that their transfer carriage did not properly engage to their sterilizer subsequently causing the transfer carriage to slide backwards.No report of injury.

• Brand Name: TRANSFER CARRIAGE
• Type of Device: TRANSFER CARRIAGE TO 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 6085016
• MDR Text Key: 59341120
• Report Number: 3005899764-2016-00078
• 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: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• 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
• Date Manufacturer Received: 10/11/2016
• 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
• Patient Outcome(s): Other