MAUDE Adverse Event Report: CONMED CORPORATION CLEANGUIDE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number DIS150

Device Problems Break (1069); Product Quality Problem (1506)

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

Event Date 04/17/2023

Event Type  malfunction  

Event Description

We have had multiple incidents where conmed disposable guide wires have snapped partially through.This issue has involved at least 2 different lot numbers that we are aware of.Prior to today, that lot number was picked up by the company's representative, exchanged and involved wire taken.The wires involved in today's incident are in procession of the hospital.The concern is that if this product were to break further into the procedure it could cause an injury or perforation in the esophagus and or stomach of patients.

• Brand Name: CLEANGUIDE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 16894579
• MDR Text Key: 314846772
• Report Number: 16894579
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/02/2023

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: DIS150
• Device Catalogue Number: DIS150
• Device Lot Number: 202211184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2023
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 05/09/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Sex: Female