MAUDE Adverse Event Report: COOK VASCULAR INC COOK-SWARTZ DOPPLER PROBE; ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Catalog Number DP-SDP001

Device Problems Defective Component (2292); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 10/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).This event is currently under investigation.A follow-up report will be generated upon the completion of the investigation.

Event Description

As reported to customer relations: "the doppler was initially working when it was put into the patient, but the crystal stopped working after the surgery was complete.The patient had to go back for a second surgery in order to replace the doppler.This required the patient to undergo a second general anesthesia, increased the risk of infection, increased the risk of neurovascular issues and delayed discharge from hospital.".

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(b)(4).Additional mfg narrative - notes - added summary of investigation investigation/evaluation summary: the returned device was inspected under magnification and the customer's complaint could be confirmed.A functional test however could not be performed as the probe wire was cut away on the returned unit.No other nonconformities or anomalies were observed on the device.A review of the device history record and manufacturing and quality control records was conducted.There is no evidence that defective product was manufactured using current drawings and device specifications.Complaints will continue to be monitored according to established complaint monitoring procedures.

• Brand Name: COOK-SWARTZ DOPPLER PROBE
• Type of Device: ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 7048212
• MDR Text Key: 92605690
• Report Number: 2522007-2017-00043
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)200731(10)N148395
• Combination Product (y/n): N
• PMA/PMN Number: K022649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DP-SDP001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/26/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1