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

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 02/16/2018

Event Type  malfunction  

Manufacturer Narrative

Product code: itx.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

The crystal detached from the cuff two days after the patients initial surgery, when the doppler was placed.The patient had to return to the operating room for a second surgery to replace the defective doppler flow probe.

Manufacturer Narrative

Investigation summary: only a portion of the complaint device was returned for an investigation.The quality engineering department performed an investigation on the portion of the device returned.The wires and crystal were returned and inspected under magnification.The investigation revealed there was epoxy on one side of the crystal, and the opposite side of the crystal did not have epoxy remaining.The proximal section of the probe was cut from the probe and not returned.A functional test could not be performed on the probe since the cable was cut and not returned for investigation.A device history record was conducted which showed no evidence that a defective product was shipped.There are no signs that this cuff was detached prior to shipment or that this device was not manufactured to current specifications.

• 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: 7381334
• MDR Text Key: 104151856
• Report Number: 2522007-2018-00011
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)200731(10)N148614
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• 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
• Date Manufacturer Received: 03/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention