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

Catalog Number DP-SDP001

Device Problems Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

Product code: itx.(b)(6).(b)(4).Event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of investigation.

Event Description

It was reported that, due to the cook-swartz doppler probe not working correctly, the patient was taken back to the operating room for a free-flap revision surgery.Once the operation started, the physician found that the crystal was detached from the probe.This additional procedure resulted in a longer hospital stay for the patient.No other patient consequences were reported.

Manufacturer Narrative

Blank fields on this form indicate information is unknown or unavailable.Investigation/evaluation summary: the device was inspected under magnification and confirmed the customer's complaint that the cuff became detached from the crystal.A functional test was performed on the probe and an audible pulse sound was verified.A functional test was performed on the probe and, when connected to the doppler monitor, the audible pulse signal was able to be verified on both sides of the crystal.No other nonconformities or anomalies were observed.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: DIAGNOSTIC ULTRASONIC TRANSDUCER
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 7203369
• MDR Text Key: 97667198
• Report Number: 2522007-2018-00004
• 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: foreign,other
• Type of Report: Initial,Followup
• Report Date: 01/26/2018

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: Health Professional
• Device Catalogue Number: DP-SDP001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 01/18/2018
• Supplement Dates Manufacturer Received: 12/21/2017
• Supplement Dates FDA Received: 02/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention