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

Catalog Number DIS150

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

Event Date 12/06/2023

Event Type  malfunction  

Event Description

Physician noticed upon removal of guidewire from the endo scope that the wire was broken at the segmentation towards the end of it.Has happened in a different instance with the same brand of guidewire but inside of the patient.In this instance, the patient was not harmed and occurred at the end of the procedure outside of the body.

• Brand Name: CONMED GUIDEWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 18337612
• MDR Text Key: 330714617
• Report Number: MW5149299
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/13/2023

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 Catalogue Number: DIS150
• Device Lot Number: 202310066
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2023
• Patient Sequence Number: 1