MAUDE Adverse Event Report: OLYMPUS CORPORATION OF AMERICAS OLYMPUS ENDOQUICK; ACCESSORIES, CLEANING, FOR ENDOSCOPE

Lot Number 23018

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 04/07/2023

Event Type  malfunction  

Event Description

Sterile processing staff identified black flecks in bottle of olympus endoquick chemical used with olympus oer machine used for flexible endoscope instrument reprocessing.This was lot # 23018, exp 7-31-2024.This was the 2nd lot # identified in madison.The previous lot was 22350 exp date 6-30-2024.The vendor sent a letter saying they are aware of the issue and the chemical is still safe to use.However, the facility has removed the product and requested replacement/credit.Reference report: mw5116535.

• Brand Name: OLYMPUS ENDOQUICK
• Type of Device: ACCESSORIES, CLEANING, FOR ENDOSCOPE
• Manufacturer (Section D): OLYMPUS CORPORATION OF AMERICAS; center valley PA 18034
• MDR Report Key: 16726059
• MDR Text Key: 313337415
• Report Number: MW5116534
• Device Sequence Number: 1
• Product Code: FEB
• 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: 04/10/2023

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 Lot Number: 23018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1