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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It was reported that after insertion, the probe detached itself in the patient as we were waiting to go to recovery after having worked fine for a while.The patient did require additional procedures due to this occurrence.Patient was returned to surgery to reopen surgical wound to identify if problem existed.Doppler probe removed.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence except more surgery time spent reopening wound.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, functional test, device history record, documentation, manufacturing instructions, quality control and visual inspection of the returned device was conducted during the investigation.The customer returned the device for evaluation.The device was examined using a microscope.Examination revealed that the epoxy separated from the crystal; epoxy is present on one side of the crystal and not the opposite side.A green residue material was observed on the crystal and a yellow / cloudy appearance where the epoxy is attached.There are no signs that this cuff was detached prior to shipment or that this device was not manufactured to current specifications.The device was functionally tested using a doppler monitor; an audible pulse signal was verified on the probe.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.Based on the information provided, examination of the returned product and the results of our investigation, a definitive root cause could not be determined; however, measures have been initiated to address this failure mode.This report accounts for one of three events reported by the user facility; reference mdr numbers 1820334-2016-01327, 2522007-2016-00008 and 2522007-2016-00009 for all associated reports.

• Brand Name: COOK-SWARTZ DOPPLER PROBE
• Type of Device: ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6122139
• MDR Text Key: 60717529
• Report Number: 2522007-2016-00009
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)190630(10)N138992
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: Yes
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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