MAUDE Adverse Event Report: COOK VANDERGRIFT INC COOK-SWARTZ DOPPLER PROBE

Model Number G21363

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/30/2021

Event Type  Injury  

Event Description

On (b)(6) 2021 after monitoring had ended, an unexpected event occurred during removal of the probe.The crystal did not detach as normal.The wire broke and remained in the patient's body.On (b)(6) 2022 a surgeon performed an additional operation to remove the crystal probe.The patient was discharged from the hospital normally and smoothly.

Manufacturer Narrative

Product code: itx.Pma/510(k): k171272.The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Manufacturer Narrative

D2b: product code: itx.G5: pma/510(k): k171272.The device was not returned on this complaint, therefore a physical investigation could not be performed and the customer's complaint could not be confirmed other than by their testimony.Per complaint: "on (b)(6) 2021, after the monitoring ended, an unexpected occurred when the probe wire was removed (the crystal sensor did not detach from the silicone cuff as normal, but the wire was interrupted, and part of the wire remained in the patient's body), we had a suggestion at that time the crystal probe should be removed.The surgeon also performed another operation to remove the crystal probe on (b)(6) 2022, and the patient was discharged from the hospital normally and smoothly." 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.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.

• Brand Name: COOK-SWARTZ DOPPLER PROBE
• 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: brian johnston ; 1186 montgomery lane; vandergrift, PA 15690 ; 7248458621
• MDR Report Key: 13580118
• MDR Text Key: 286647621
• Report Number: 2522007-2022-00005
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)240630(10)N181192
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G21363
• Device Catalogue Number: DP-SDP001
• Device Lot Number: N181192
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• 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