MAUDE Adverse Event Report: COOK VASCULAR, INC. COOK-SCHWARTZ DOPPLER FLOW PROBE STANDARD CUFF; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Catalog Number SDP-001

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Date 10/29/2015

Event Type  malfunction  

Event Description

Probe was defective; missing cuff.They were able to get another probe and complete the case.

• Brand Name: COOK-SCHWARTZ DOPPLER FLOW PROBE STANDARD CUFF
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): COOK VASCULAR, INC.; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 5359672
• MDR Text Key: 35619213
• Report Number: 5359672
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2016,01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Unknown
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: SDP-001
• Device Lot Number: N130991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/05/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR