MAUDE Adverse Event Report: STERIS CORPORATION STERIS ULTRASONIC CLEANER; CLEANER, ULTRASONIC, MEDICAL INSTRUMENT

Model Number IWPCF

Device Problems Product Quality Problem (1506); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2022

Event Type  malfunction  

Event Description

Original equipment manufacturer (oem) unable to complete preventative maintenance (pm) on ultrasonic cleaner per oem schedule due to back ordered pm parts.Equipment is on full support contract (pm and repair) by oem.Site has safety and regulatory concern due to missed maintenance for device that sterilizes high risk instruments and equipment.Fda safety report id# (b)(4).

• Brand Name: STERIS ULTRASONIC CLEANER
• Type of Device: CLEANER, ULTRASONIC, MEDICAL INSTRUMENT
• Manufacturer (Section D): STERIS CORPORATION
• MDR Report Key: 14934800
• MDR Text Key: 295453221
• Report Number: MW5110691
• Device Sequence Number: 1
• Product Code: FLG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IWPCF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other