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

Model Number	CD-B612LA
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Bicoag hemostasis probe 10 fr end broke in scope.

• Brand Name: 10FR FIXEDPIN HEMOSTATIC PROBE
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana ave north; brooklyn park MN 55445
• MDR Report Key: 18586673
• Report Number: 18586673
• Device Sequence Number: 20602076
• Product Code: KNS
• UDI-Device Identifier: 00821925039476
• UDI-Public: (01)00821925039476(17)241025(10)KR144716
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2023
• Report Date (Section F): 10/11/2023

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
• Operator of Device: Other
• Device Model Number: CD-B612LA
• Device Lot Number: KR144716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 176 KG
• Date Report Sent to FDA: 10/11/2023