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

Model Number CD-B612LA

Device Problems Break (1069); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2019

Event Type  malfunction  

Event 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
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): GYRUS ACMI, INC.; 2400 ringwood ave.; san jose CA 95131
• MDR Report Key: 8869340
• MDR Text Key: 153545532
• Report Number: 8869340
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00821925039476
• UDI-Public: (01)00821925039476(17)200721(10)MK669752
• 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: 07/16/2019,07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD-B612LA
• Device Lot Number: MK669752
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Weight: 112