MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 66" TRANSFER CAR; TRANSFER CAR TO STERILIZER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 10/22/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The steris service technician was not made aware of an injury while onsite.He was dispatched to the user facility via a service request stating that the front wheels of their transfer carriage were not locking properly.A steris service technician inspected the transfer carriage and found that all four wheels on the carriage required adjustment.The technician also leveled the transfer carriage and confirmed it to be operating properly.The transfer carriage was returned to service and no additional issues have been reported.The steris technician stated that the floors at this facility are uneven, so each transfer carriage has to be assigned to a specific sterilizer.Depending on the degree of the floor unevenness, if an employee tried to use the carriage on a different sterilizer, it could have damaged the latching mechanism or not allowed the latching mechanism to engage and disengage properly as the carriage may not be properly adjusted for the sterilizer.The steris technician made user facility personnel aware of this.

Event Description

The user facility reported that an employee was undocking the transfer carriage from the sterilizer when the carriage began to tip.The employee attempted to stop the carriage from falling and subsequently broke her ankle.

• Brand Name: 66" TRANSFER CAR
• Type of Device: TRANSFER CAR 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: 5240146
• MDR Text Key: 31968607
• Report Number: 3005899764-2015-00080
• 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: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2015
• 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