MAUDE Adverse Event Report: TERUMO CORP SINGLE USE GUIDEWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number G-240-2527S

Device Problem Break (1069)

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

Event Date 12/17/2023

Event Type  Injury  

Event Description

A user facility reported to olympus that the single use guidewire tip broke during an endoscopic retrograde cholangiopancreatogram and was successfully retrieved from the patient.Additional information was requested multiple times but was not received.This event requires two reports as the reporter was unsure which device failed (two separate lot numbers).Patient identifier (b)(6) is for lot 36k.Patient identifier (b)(6) is for lot 33k.This report is for (b)(6).

• Brand Name: SINGLE USE GUIDEWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO CORP; 44-1, 2-chome, hatagaya; shibuya-ku, tokyo 151-0 072; JA 151-0072
• MDR Report Key: 18504188
• MDR Text Key: 332791051
• Report Number: 2429304-2024-00022
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 04953170282744
• UDI-Public: 04953170282744
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2023,01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G-240-2527S
• Device Lot Number: 33K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention