MAUDE Adverse Event Report: MIDMARK CORPORATION MIDMARK; STEAM STERILIZER

Model Number M11-002

Device Problems Unintended Ejection (1234); Explosion (4006)

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

Event Date 10/03/2018

Event Type  malfunction  

Manufacturer Narrative

Midmark has become aware of an incident where a m11-002 steam sterilizer ejected the sterilizer tray, including the sterilizer contents.The likely failure mode was the result of the user failing to completely close the sterilizer door prior to initiating a cycle.Midmark believes this issue is the result of not following the instructions per (b)(4).Additionally, this product has exceeded its defined product life of 10 years and has been discontinued by midmark.Due to the product being past its useful life it was recommended the user dispose of the device, and the customer has stated the sterilizer is no longer in operation.

Event Description

User claimed the door opened under pressure ejecting the sterilizer tray, along with the items being sterilized, causing damage to the room wall and ceiling.No injuries occurred as a result of this event.

• Brand Name: MIDMARK
• Type of Device: STEAM STERILIZER
• Manufacturer (Section D): MIDMARK CORPORATION; 60 vista dr.; versailles OH 45380
• Manufacturer (Section G): MIDMARK CORPORATION; 60 vista dr.; versailles OH 45380
• Manufacturer Contact: adam clutter ; 60 vista dr.; versailles, OH 45380 ; 8006436275
• MDR Report Key: 8361516
• MDR Text Key: 137420163
• Report Number: 1523530-2019-00001
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K936181
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M11-002
• Device Catalogue Number: M11-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/1998
• 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