MAUDE Adverse Event Report: PHILIPS ULTRASOUND LLC TRANSDUCER 3D9-3V; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	989605395622
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
When exam was complete, philips transvaginal probe broke in half during routine transvaginal exam, as sonographer was removing probe from patient.Sonographer notified philips.The issue is the same issue as describe in a large recall for similar devices.However, this particular device is not listed in the recall, so philips will not cover replacement.Manufacturer response for transducer, ultrasonic, diagnostic, transducer 3d9-3v (per site reporter).The manufacturer will not cover cost of replacement of device.The issue is the exact same as defects on a recall list, but this particular model is not on the list.

• Brand Name: TRANSDUCER 3D9-3V
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND LLC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 18064221
• Report Number: 18064221
• Device Sequence Number: 12772963
• Product Code: ITX
• UDI-Device Identifier: 00884838061545
• UDI-Public: (01)00884838061545
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/24/2023
• Report Date (Section F): 10/26/2023

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: 989605395622
• Device Lot Number: B28BFQ
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 11/03/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 122 KG
• Patient Race: Black Or African American
• Date Report Sent to FDA: 10/26/2023