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 Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Medical device did not function as expected and could not be used on patient - replacement by vendor requested.The tip which delivers the electrical charge to the patient "was not intact," and that the device would not work.

• Brand Name: 10FR FIXEDPIN HEMOSTATIC PROBE
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): GYRUS ACMI, INC.; 2400 ringwood ave.; san jose CA 95131
• MDR Report Key: 8869340
• Report Number: 8869340
• Device Sequence Number: 618064
• Product Code: KNS
• UDI-Device Identifier: 00821925039476
• UDI-Public: (01)00821925039476(17)200721(10)MK669752
• 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): 07/12/2019
• Report Date (Section F): 07/16/2019

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: Health Professional
• Device Model Number: CD-B612LA
• Device Lot Number: MK669752
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 112
• Date Report Sent to FDA: 07/16/2019