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

Model Number G21363

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 10/28/2017

Event Type  malfunction  

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 Description

As reported to customer relations: ": (b)(6) ¿ the crystal prematurely separated from the cover after the surgery was complete.The patient had to return to the operating room for a second surgery to have a new doppler put in.".

Manufacturer Narrative

Investigation summary: complaint was evaluated and confirmed via customer testimony.Device was not returned so no physical investigation could be conducted.Product literature was reviewed and this is a known failure mode of the device which will continue to be monitored according to established complaint monitoring procedures.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.A summary of the investigation has been sent to the complainant.

Manufacturer Narrative

Additional information: h6- ec method code desc - 1: changed to testing of actual/suspected device (10).H6- ec method code desc - 2: changed to historical data analysis (4109).H6- ec results code desc - 1: changed to manufacturing process problem identified (170).H6- ec conclusions code desc - 1: changed to cause traced to manufacturing (25).H10- added summary of investigation.Investigation-evaluation: device was returned to cvi on 20apr2020.The device was used.When performing a visual inspection, the cuff was indeed detached from the crystal.Visual inspection confirmed the customer's complaint.The probe was inspected under magnification, there is epoxy on one side of the crystal, and the opposite side of the crystal did not have epoxy remaining.The device history record (dhr) was reviewed and showed no signs that the cuff was detached prior to shipment or that the device was not manufactured to current specification.This is a known failure mode, and is being tracked/trended per the post market surveillance and complaint handling processes at cvi.Crystal detachment from cuff is addressed per capa 161942.A risk assessment was performed via qera 171221.1.Per ifu (d00078672 rev003): "device specific risks include separation of the doppler crystal from the cuff, inability to percutaneously remove the crystal after monitoring is complete, loss of reception or transmission of ultrasound monitoring signal." , "upon removal from package, inspect the product to ensure no damage has occurred." this report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No new information regarding the event has been reported, however the complaint device was returned to the manufacturer for a physical investigation on 20april2020.

• Brand Name: COOK-SWARTZ DOPPLER PROBE
• Type of Device: ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 7048197
• MDR Text Key: 92605297
• Report Number: 2522007-2017-00045
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G21363
• Device Catalogue Number: DP-SDP001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Date Manufacturer Received: 11/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.