MAUDE Adverse Event Report: GYRUS ACMI, INC. 10FR COAX HEMOSTATIC PROBE; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number CD-B610LA

Patient Problem Insufficient Information (4580)

Event Date 01/19/2023

Event Type  malfunction  

Event Description

When retrieving the olympus america bicoag single-use bipolar probe from the scope after use, the tip broke off.It was still attached to the probe by the probe wires, but the tip was broken.

• Brand Name: 10FR COAX HEMOSTATIC PROBE
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana ave north; brooklyn park MN 55445
• MDR Report Key: 18245837
• MDR Text Key: 329477960
• Report Number: 18245837
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2023

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 Model Number: CD-B610LA
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1