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

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

Patient Problems Fall (1848); Injury (2348)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

During the time of the reported event, the employee was walking to the front of the sterilizer when they inadvertently tripped on the side of a transfer carriage causing the employee to fall forward and their hand to land in between the sterilizer's door and hinge cover.The unit was not running a cycle during the time of the event and the employee called for assistance as their hand was stuck.Following the event, a steris technician arrived onsite to inspect the sterilizer and found the unit to be operating according to specification; no repairs were required.The sterilizer was installed at the customer's location in 2015 and is not under steris service agreement for maintenance activities.No additional issues have been reported.

Event Description

The user facility reported that an employee injured their hand after falling onto the amsco 400 sterilizer.No report of procedure delay or cancellation.The employee sought medical treatment and returned to work.

• 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 7605620
• MDR Text Key: 111899180
• Report Number: 3005899764-2018-00042
• 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: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2018
• 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