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

Catalog Number	DP-SDP001
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/11/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: DIAGNOSTIC ULTRASONIC TRANSDUCER
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 7203369
• Report Number: 2522007-2018-00004
• Device Sequence Number: 18865834
• 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: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: DP-SDP001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention