MAUDE Adverse Event Report: FLEXIBLE SCOPE, LARGE DIAMETER VIDEO COLONOSCOPE OLYMPUS CF-HQ190L

Model Number CF-HQ190L

Device Problem Partial Blockage (1065)

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

Event Date 06/14/2023

Event Type  malfunction  

Manufacturer Narrative

During a procedure on (b)(6) 2023, the water spray function was not producing as much water flow as it should.Under previous repair, srn (b)(6), the device auxiliary water channel had been cleared during said servicing.After the needed repair had been completed, the device had passed outgoing qc inspection with no functional issues noted prior to returning to the customer.The device in question was returned to the lab on (b)(6) 2023 for evaluation under srn (b)(6).Upon investigation, the lab confirmed the customer's reported issue with the auxiliary water channel function.The issue was found to be due to a slight restriction in the auxiliary water channel opening at the c-cover.The water channel in question had a clog that had been cleared during the previous servicing, however there was still a small amount of excess adhesive present in the auxiliary water channel opening at the c-cover which partially restricted the flow out of the channel.It was concluded that the blockage was due to technician error during previous device servicing.Technicians will receive refresher training on wi-flex-005.014.To address the customer's concerns the following repairs were performed on the device: aux901: auxiliary water channel cleared (190 series), and noz903 a/w nozzle glue refurbished (190 series).On (b)(6) 2023 the repaired device passed outgoing qc inspection and was returned to the customer.No further investigation is required.

Event Description

The user facility reported that the water spray function was not working properly during a procedure (was not spraying straight/low flow).No injury was reported, however there was a delay as it took longer to rinse than it should have.

• Brand Name: FLEXIBLE SCOPE, LARGE DIAMETER VIDEO COLONOSCOPE OLYMPUS CF-HQ190L
• Type of Device: COLONOSCOPE
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 17353960
• MDR Text Key: 319390724
• Report Number: 1527821-2023-00002
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-HQ190L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1