MAUDE Adverse Event Report: STRYKER CORPORATION; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number 3302379

Device Problem Communication or Transmission Problem (2896)

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

Event Date 02/17/2020

Event Type  malfunction  

Event Description

Stryker josephson ep catheter distal electrode without signal during ablation procedure.

• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical court; san jose CA 95138
• MDR Report Key: 10074454
• MDR Text Key: 191552650
• Report Number: 10074454
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/24/2020

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 Operator: Health Professional
• Device Model Number: 3302379
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8395 DA