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

Model Number	N/A
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/27/2017
Type of Reportable Event	Serious Injury
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
The customer reported that, during a pharyngeal-mandibular tumor excision with an anterior lateral thigh osteo-cutaneous free tissue transfer, the cook-swartz doppler probe signal became faint.This reportedly occurred in the intensive care unit, 4 hours status post procedure.The patient had to return to the operating room due to this reported decrease in the doppler signal, which is believed to be secondary to a faulty implantable doppler wire.The patient received unintended anesthesia, and an operation to determine the cause of the decrease in doppler signal.The device is reportedly unavailable for return.
Additional Manufacturer Narrative
Investigation summary: complaint was evaluated and confirmed via customer testimony.Device was not returned so no physical examination could be conducted.Product literature was reviewed and the instructions for use list potential loss of reception or transmission of ultrasound monitoring signal as a potential adverse event.Also included in the ifu is crystal separation as a known failure mode.The device history record was also reviewed and there is no evidence that a defective product was shipped.A review of the finished assembly drawing showed no signs that cuff was detached prior to shipment or that the device was not manufactured to current specifications.Review of the complaint history showed that the event falls within the scope of an internal corrective action performed on this product.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: 6983447
• Report Number: 2522007-2017-00032
• Device Sequence Number: 19132000
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)200630(10)N147631
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K022649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2018

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
• 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: 09/28/2017
• Supplement Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 10/27/2017
• 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: 70 YR