MAUDE Adverse Event Report: PHILIPS ULTRASOUND LLC TRANSDUCER X8-2T; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	989605455171
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Situation: transesophageal echocardiogram (tee) probe rubber sheath was not intact when probe removed from patient¿s esophagus at the end of procedure.Tee probe was intact prior to insertion.Background: patient underwent routine tee with bite block in place.When probe was removed and cardiologist passed the probe to echo tech, she wiped it down as per usual practice and she noted a 1-1.5¿ piece of the probe covering (black, soft rubber) was missing.She notified the cardiologist and the registered nurse (rn) who were also at bedside and all looked for the piece in the bed, trash, linen, etc.The missing piece was not found.The patient had a ct scan and results do not show any ¿discernable radiopaque foreign object¿ or evidence of bowel obstruction.The tee probe was sequestered and subsequently, biomed took possession of the probe with intent on sending back to philips.

• Brand Name: TRANSDUCER X8-2T
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND LLC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 19905412
• Report Number: 19905412
• Device Sequence Number: 7080698
• Product Code: ITX
• UDI-Device Identifier: 00884838069718
• UDI-Public: (01)00884838069718(90)989605455171(91)453561842277
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/29/2024
• Report Date (Section F): 05/29/2024

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: 989605455171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 1 YR
• Date Report to Manufacturer: 08/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/29/2024