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

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 09/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the cook-swartz doppler probe doppler wires were coming loose post operatively, which necessitated the reopening of the patient's neck incision to determine what resulted in the loss of the doppler signal.The doppler malfunction reportedly directly contributed to the additional medical intervention.The patient's original procedure was a pharyngectomy with anterior lateral thigh free tissue transfer.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Failure mode identified as defect code no.314, bond separation, which equates to the dfmea failure mode of "inadvertent cuff detachment, prior to, during or post procedure." dhr was reviewed and no discrepancies were found.Review of the complaint history identified trends and the event has been escalated within our internal processes (capa).The relevant capa was closed on december 6, 2017.A summary of the investigation has been sent to the complainant.

• 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6977047
• MDR Text Key: 90232107
• Report Number: 2522007-2017-00031
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)200531(10)N147138
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: DP-SDP001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/27/2017
• Initial Date FDA Received: 10/25/2017
• Supplement Dates Manufacturer Received: 09/27/2017
• Supplement Dates FDA Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR