MAUDE Adverse Event Report: CONMED CORPORATION CLEANGUIDE - DISPOASABLE MARKED SPRING TIP GUIDEWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number DIS150

Patient Problem Foreign Body In Patient (2687)

Event Date 11/14/2023

Event Type  Injury  

Event Description

A guidewire was introduced into the patient's stomach in order to utilize for a subsequent dilation of the esophagus.The majority of the tip of the wire broke off into the patient's stomach.Luckily, the md was able to retrieve and remove it from the patient's stomach.

• Brand Name: CLEANGUIDE - DISPOASABLE MARKED SPRING TIP GUIDEWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 18173795
• MDR Text Key: 328696997
• Report Number: MW5148307
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/15/2023

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 Lot Number: 202310104
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention