MAUDE Adverse Event Report: SOLMETEX (STERISIL) STERISIL G5; UNIT, OPERATIVE DENTAL

Model Number G5

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

Event Date 12/26/2023

Event Type  malfunction  

Event Description

A water filtration unit failed multiple times due to a known faulty flowmeter, flooding our sterile processing department causing sterilization to be halted and impacting our ability to facilitate patient care.Part was replaced recently due to same problem.Manufacturer tech support listed part as a common point of failure.Flowmeter is identified as part #10 on unit schematics attached near the bladder tank.Specifically the flowmeter fails orthogonally to the part as it explodes due to over pressure for the material.Clearly a case of bad manufacturing that will continue to cause problems that will impact patient care operations.

• Brand Name: STERISIL G5
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): SOLMETEX (STERISIL)
• MDR Report Key: 18419235
• MDR Text Key: 331715696
• Report Number: MW5149674
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2023
• Patient Sequence Number: 1