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

Catalog Number	DP-SDP001
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Explanting the doppler probe resulted in an incomplete removal of the probe.The removed part was disposed, the distal part of the probe left in situ.It is not clear yet whether the incomplete removal is due to cutting or tearing off.A meeting with the dr.To complete this information could not take place earlier, and is scheduled on 24th october.Nonetheless we wanted to provide you this information already.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.G5 ¿ pma/510(k): 171272.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.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
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.G5 ¿ pma/510(k): 171272.The entire device was not returned - only six small pieces of wire were returned on this complaint.The complaint/event that was entered and reported within trackwise: "explanting the doppler probe resulted in an incomplete removal of the probe." the quality assurance department performed the investigation of this doppler probe.A functional test was unable to be performed due to only six small pieces of wires being returned.Per customer complaint information: "explanting the doppler probe resulted in an incomplete removal of the probe.The removed part was disposed, the distal part of the probe left in situ.It is not clear yet whether the incomplete removal is due to cutting or tearing off.A meeting with the dr.To complete this information could not take place earlier, and is scheduled on 24th october.Nonetheless we wanted to provide you this information already." and per customer complaint attachment, the wires returned were stated to have been the ones that were surgically removed by staff that may have used an instrument pulling the probe, which could explain some of the damages." the device was inspected under magnification.During the visual investigation, there was blood present on the wires along with a blood clot/calcification present on the wire.The ends of the wires were appearing thinner than the wire itself and some appear to have a mild twist in them.The piece that was returned with the crystal showed that there was epoxy present on the crystal and the wire was attached to both sides of the crystal.The device history record (dhr) was reviewed, including quality control and manufacturing records.There were no signs of a manufacturing nonconformity found or that the device was shipped to the field nonconforming.The complaint will be monitored per the cook vandergrift inc.Complaint handling and post market surveillance processes.A risk assessment will be performed and documented in the complaint summary tab in trackwise.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
Explanting the doppler probe resulted in an incomplete removal of the probe.The removed part was disposed, the distal part of the probe left in situ.It is not clear yet whether the incomplete removal is due to cutting or tearing off.A meeting with the dr.To complete this information could not take place earlier, and is scheduled on 24th october.Nonetheless we wanted to provide you this information already.

• 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
• Manufacturer (Section G): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: timothy vogel ; 1186 montgomery lane; vandergrift, PA 15690 ; 7248458621
• MDR Report Key: 18010747
• Report Number: 2522007-2023-00023
• Device Sequence Number: 7314278
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)250131(10)N185885
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2024

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 Expiration Date: 01/31/2025
• Device Catalogue Number: DP-SDP001
• Device Lot Number: N185885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DP-CAB01; DP-CAB01; DP-M350; DP-M350
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female