MAUDE Adverse Event Report: STERIS CORPORATION REVITAL-OX RESERT HIGH LEVEL DISINFECTANT; STERILANT

Device Problem Use of Device Problem (1670)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 08/30/2021

Event Type  malfunction  

Event Description

The user facility contacted steris as part of their investigation into an event which occurred during an endoscopy procedure.

Manufacturer Narrative

The user facility reported that they observed a small chemical burn on the patient's gastrointestinal tract during the procedure which resulted in a procedure delay.No treatment was administered.The procedure was completed successfully.Following notification of the reported event, a steris account manager spoke with user facility personnel and learned that the scope used during the procedure had been manually cleaned with revital-ox resert high level disinfectant and dried with non-steris alcohol.Based on the description of the event and the discussion with user facility personnel, it is likely that they did not properly rinse and dry the scope prior to use.The revital-ox resert high level disinfectant instructions for use include the following directions, "following removal from revital-ox resert high level disinfectant solution, thoroughly rinse the medical device by immersing it completely in water.Keep the instrument or medical device immersed for a minimum of 1 minute in duration, unless longer is specified by the instrument manufacturer.Manually flush all lumens with large volumes of water (at minimum 100 ml) unless otherwise noted by the instrument manufacturer.Remove device and discard rinse water.Do not reuse the water for rinsing or any other purpose.A final rinse using a 70% isopropyl alcohol solution (followed by medical air purge if within lumens) may be used to speed the drying process.Follow facility policies.Consult the instrument manufacturer's instructions for recommended rinsing and drying procedure." steris offered an in-service training on the proper use of revital-ox resert high level disinfectant, specifically, properly rinsing and drying of medical devices; however, the user facility declined.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: REVITAL-OX RESERT HIGH LEVEL DISINFECTANT
• Type of Device: STERILANT
• Manufacturer (Section D): STERIS CORPORATION; 7501 page avenue; st. louis MO 63133
• MDR Report Key: 12547503
• MDR Text Key: 281333479
• Report Number: 1937531-2021-00002
• Device Sequence Number: 1
• Product Code: MED
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1