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

Model Number IWPCF

Device Problem Device Difficult to Maintain (3134)

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

Event Date 02/28/2023

Event Type  Injury  

Event Description

Original equipment manufacturer (oem) unable to complete preventative maintenance (pm) on 1 (one) ultrasonic cleaner per the schedule set out by the oem due to no available pm kits.Site has safety and regulatory concern due to missed maintenance for devices as they are necessary for sterilizing surgical instruments.Ongoing and unresolved back order issues with oem put patients at risk.

• Brand Name: INNOWAVE PCF ULTRASONIC CLEANER
• Type of Device: CLEANER, ULTRASONIC, MEDICAL INSTRUMENT
• Manufacturer (Section D): STERIS CORPORATION
• MDR Report Key: 16487084
• MDR Text Key: 310795113
• Report Number: MW5115425
• 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: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• 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): Required Intervention