MAUDE Adverse Event Report: CooperSurgical, Inc. CooperSurgical; Swartz Doppler Probe

Model Number	DP-SDP001
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hospital is having issues with the probe performance.Hospital reported that they had discarded defective devices.Additional communication revealed that the issues they have been having are related to sound.They cannot hear the sound waves from the probe when applied to the vessel.No patient harm reported.No additional information is available.(b)(6).
Additional Manufacturer Narrative
B3: between (b)(6) 2026.Device has been discarded.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: CooperSurgical
• Common Device Name: Swartz Doppler Probe
• Manufacturer (Section D): CooperSurgical, Inc.; 95 corporate drive; trumbull CT 06611 -135
• Manufacturer (Section G): CooperSurgical, Inc.; 75 corporate drive; trumbull CT 06611 -135
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611--135 ; +1(475)265-1582
• MDR Report Key: 50476908
• Report Number: 1216677-2026-00105
• Device Sequence Number: 10093719
• Product Code: ITX
• UDI-Device Identifier: 00888937027792
• UDI-Public: (01)00888937027792
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DP-SDP001
• Device Catalogue Number: DP-SDP001
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown