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

Catalog Number	DP-SDP001
Medical Device Problem Codes	Defective Component (2292); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.A follow-up report will be generated upon the completion of the investigation.
Event or Problem 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.".
Additional 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
• Common Device Name: ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 7048212
• Report Number: 2522007-2017-00043
• Device Sequence Number: 1450574
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)200731(10)N148395
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DP-SDP001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1