MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO 400 STERILIZER

Device Problem Connection Problem (2900)

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

Event Date 09/16/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The user facility stated that the transfer car did not line up properly with the track, which almost caused the transfer car to tip and fall.All instruments involved with the reported event were properly reprocessed in a different sterilizer.A steris service technician arrived onsite to inspect the sterilizer and transfer car.The technician found no issues with the function or operation of the transfer car.The steris service technician inspected the sterilizer and confirmed the latching mechanism inside the sterilizer required adjustment.The technician stated the sterilizer's chamber tracks and guide bracket were out of alignment.As the sterilizer's chamber tracks were out of alignment it did not allow the transfer car to be properly loaded inside the sterilizer chamber.The sterilizer is under steris warranty.The technician properly adjusted the sterilizer's chamber tracks, tested the unit and confirmed the equipment to be operating properly.No additional issues have been reported.

Event Description

The user facility reported that their transfer car did not properly lock into their amsco 400 sterilizer almost causing the transfer car to tip.No injury, procedural delay, or cancellation was reported.

• Brand Name: AMSCO 400 STERILIZER
• Type of Device: 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: 6030696
• MDR Text Key: 57733737
• Report Number: 3005899764-2016-00073
• 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: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• 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: 09/16/2016
• 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