MAUDE Adverse Event Report: COOPERSURGICAL, INC. COOPERSURGICAL; SWARTZ DOPPLER PROBE

Model Number	DP-SDP001
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a diep flap procedure, the physician placed a cook doppler probe in this patient.It was accidentally broken and needed to be replaced.Six probes were opened, and none of them were functional.The patient was taken out of the operating room without an implanted doppler probe.Flap monitoring is being accomplished with a pencil doppler, which is less than optimal and not the usual standard of care.1216677-2026-00041 dp-sdp001 swartz probe (b)(4).

• Brand Name: COOPERSURGICAL
• Common Device Name: SWARTZ DOPPLER PROBE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611 1350
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611 1350
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611-1350 ; 4752651582
• MDR Report Key: 25334511
• Report Number: 1216677-2026-00041
• Device Sequence Number: 9675567
• Product Code: ITX
• UDI-Device Identifier: 00888937027792
• UDI-Public: (01)00888937027792(10)550024872
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DP-SDP001
• Device Catalogue Number: DP-SDP001
• Device Lot Number: 550024872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/29/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White