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

Model Number	N/A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
It was reported that the patient underwent an esophagectomy procedure with jejunal graft.The physician attached a cook-swartz doppler probe but it malfunctioned.The physician used another cook-swartz doppler probe, which functioned for a certain amount of time, but later failed.The patient underwent two additional procedures in relation to this issue since the physician was not able to detect the blood flow via the probe.Additional information was requested regarding the failure of the device and the two additional procedures.No additional information has been provided at this time.
Additional Manufacturer Narrative
Investigation/evaluation: complaint was evaluated and reported event was confirmed via customer testimony, review of complaint history, review of device history record, and review of documentation.The instructions for use list a loss of reception or transmission of ultrasound monitoring signal as a potential adverse event.The device history record was reviewed, including the manufacturing and quality control records, and there were no signs to indicate that nonconforming devices were sent to the field.The root cause is unable to be determined because the device was not returned; therefore, a physical investigation could not be performed.A summary of the investigation has been sent to the complainant.

• 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: 6499539
• Report Number: 2522007-2017-00015
• Device Sequence Number: 19022641
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)190930(10)N141043.1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K022649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2018

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 Model Number: N/A
• Device Catalogue Number: DP-SDP001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2017
• Supplement Date Received by Manufacturer: 03/20/2017
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 02/02/2018
• 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
• Patient Age: 77 YR