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

Model Number	G21363
Medical Device Problem Codes	No Audible Prompt/Feedback (2282); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicated the information is unknown, unchanged, or unavailable.The udi information per 21cfr 803.52(c)(4) and 21 cfr 803.50(b) that is required is reasonably unknown due to the device itself was discarded/not returned at this time for investigation after manufacturer requested for the return.The event is currently under investigation.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available or upon completion of investigation.E3 - occupation: unknown.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 or Problem Description
When the doppler was being implanted into the patient on (b)(6) 2025, when connected to the doppler machine, there was a loud squealing noise but the doppler read appropriately.On (b)(6) the doppler stopped reading completely and the patient had to be brought back to the operating room to get the doppler exchanged.It seemed like the wires on the doppler were twisted and that's why it wasn't working properly.
Additional Manufacturer Narrative
The udi information per 21cfr 803.52(c)(4) and 21 cfr 803.50(b) that is required is reasonably unknown due to the device itself was discarded/not returned at this time for investigation after manufacturer requested for the return.The event is still currently under investigation.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available or upon completion of investigation.E3: occupation: unknown.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 or Problem Description
When the doppler was being implanted into the patient on (b)(6) 2025, when connected to the doppler machine, there was a loud squealing noise but the doppler read appropriately.On (b)(6), the doppler stopped reading completely and the patient had to be brought back to the operating room to get the doppler exchanged.It seemed like the wires on the doppler were twisted and that's why it wasn't working properly.
Event or Problem Description
When the doppler was being implanted into the patient on (b)(6) 2025, when connected to the doppler machine, there was a loud squealing noise but the doppler read appropriately.On (b)(6) the doppler stopped reading completely and the patient had to be brought back to the operating room to get the doppler exchanged.It seemed like the wires on the doppler were twisted and that's why it wasn't working properly.
Additional Manufacturer Narrative
Blank fields on this form indicated the information is unknown, unchanged, or unavailable.The udi information per 21cfr 803.52(c)(4) and 21 cfr 803.50(b) that is required is reasonably unknown due to the device itself was discarded/not returned at this time for investigation after manufacturer requested for the return.No updates were made within this report.The event is still currently under investigation.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available or upon completion of investigation.E3 - occupation: unknown 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.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information, the manufacturer's investigation of the returned device, and to correct what was previously provided in section 7a (is this a single-use device that was reprocessed and reused on a patient? no).One used dp-sdp001 was returned for this complaint.The quality assurance department evaluated the returned, used device.Visually the device was in three separate parts.The device parts were viewed under increased magnification.One of the returned parts was the component with the clear flaps - the blue cord appeared to have been cut, along with a blue thread in the clear flap, and a portion of the silver wire appeared to have been ripped/cut as well.The second of the returned parts was a portion of the silver wire which did not have the cuff returned, nor was it attached to the crystal.The crystal was present and the silver wire appeared to have been cut/unraveled.The third part was the blue cord with the red connector at the distal end, which also appeared to have been cut.Blood was observed throughout the device parts.The returned device was not able to be functionally tested due to the components being cut.It is unclear what may have caused the loud squealing noise.The complaint has been acknowledged but could not be confirmed as the device could not be functionally evaluated.The device history record (dhr) was reviewed, including manufacturing and quality control records and there are no signs to indicate that the device was not manufactured to current specifications.This complaint mode is being monitored, tracked and trended per the cvi post market surveillance and complaint handling processes.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.

• Brand Name: COOK-SWARTZ DOPPLER PROBE
• Common Device Name: ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): COOK VANDERGRIFT INC.; 1186 montgomery lane; vandergrift PA 15690 6065
• Manufacturer (Section G): COOK VANDERGRIFT INC.; 1186 montgomery lane; vandergrift PA 15690 6065
• Manufacturer Contact: kimberly platt ; 1186 montgomery lane; vandergrift, PA 15690-6065 ; 7248458621
• MDR Report Key: 22027800
• Report Number: 2522007-2025-00006
• Device Sequence Number: 12887632
• Product Code: ITX
• UDI-Device Identifier: 10827002213637
• UDI-Public: (01)10827002213637(17)271130(10)N210659
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K171272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: G21363
• Device Catalogue Number: DP-SDP001
• Device Lot Number: N210659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; 01/05/2026
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 08/08/2025; 11/06/2025; 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown