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

Model Number	DP-SDP001
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tranmandibular resection, bilateral neck dessection, reconstruction with left radial freeflap, doppler probes were determined to be defective.New probe was opened to complete the surgery.No patient harm reported.(b)(4) dp-sdp001 swartz probe (b)(4).
Additional Manufacturer Narrative
G2: foreign: canada.Device location is unknown.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: 50917819
• Report Number: 1216677-2026-00151
• Device Sequence Number: 14800956
• Product Code: ITX
• UDI-Device Identifier: 00888937027792
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 550033719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/28/2026
• 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