MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC TRANSDUCER X8-2T

Model Number	989605455171
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial visual inspection identified a rough surface on the distal tip of the transducer, adjacent to the lens.Further evaluation of the transducer will be included in a follow up report upon its return and investigation completion.
Event or Problem Description
A customer reported encountering an incident where a patient sustained an injury during an examination with an x8-2t model transducer.Upon completion of a transesophageal echocardiogram study, blood was found on the transducer as it was withdrawn from the patient.Further investigation found the patient had received a laceration to their esophagus.The injury was treated medically and no additional surgical intervention was required.
Additional Manufacturer Narrative
A thorough evaluation of the x8-2t model transducer identified extensive damage to the device.Initial visual inspection noted the tip shell had scrape marks and appeared melted.Protein build up, discolored cable and knobs, worn i-tube and a wrinkled array window were also evident.The evaluation concluded the appearance and condition of the tip shell would not have been caused by the insertion or use within a patient and would have been present prior to use.The exact cause of the damage could not be determined, however, philips concludes that this is not a manufacturing or design based defect and is indicative of improper maintenance.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: TRANSDUCER X8-2T
• Common Device Name: TRANSDUCER
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 8621810
• Report Number: 3019216-2019-00023
• Device Sequence Number: 2259804
• Product Code: ITX
• UDI-Device Identifier: 00884838069718
• UDI-Public: (01)00884838069718
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K163120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 989605455171
• Device Lot Number: B295RQ
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention