MAUDE Adverse Event Report: ONE TAB ENZYMATIC CLEANER; ACCESSORIES, CLEANING, FOR ENDOSCOPE

Device Problems Product Quality Problem (1506); Use of Device Problem (1670)

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

Event Date 07/22/2021

Event Type  malfunction  

Event Description

One tab enzymatic cleaner - the product is used for cleaning/disinfection of endoscopes.It is marketed for use with 7 gallons of water; however, the product is not effective when used with that much water.The firm has received customer complaints associated with low concentrations.Complainant stated she raised concerns about the product and suggested a larger pouch of the product be sold to be used with 7 gallons.Complainant was told increasing the pouch size was too expensive and was directed to increase one of the enzymes.Complainant stated increasing this enzyme would cause the product to be detected on the serim brand test strips but not increase effective or concentration of the active ingredients.It would cause the consumer who is testing the solution to believe it is mixed at an appropriate concentration when it is not; the change is being implemented soon.

• Brand Name: ONE TAB ENZYMATIC CLEANER
• Type of Device: ACCESSORIES, CLEANING, FOR ENDOSCOPE
• MDR Report Key: 12276880
• MDR Text Key: 265366862
• Report Number: MW5103000
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/28/2021

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: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2021
• Patient Sequence Number: 1