MAUDE Adverse Event Report: PHILIPS ULTRASOUND AFFINITI 50; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	989605410251
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to philips that their 3d9-3v c9-4v vaginal transducer broke while in use during a patient exam.There was no report of harm associated with this issue.
Additional Manufacturer Narrative
Philips field service engineering replaced the c9-4v transducer.Return of the suspect transducer is anticipated.Evaluation of the transducer will be included in a follow up report upon its return and investigation completion.
Additional Manufacturer Narrative
An r&d investigation was performed to identify the root cause of the reported issue.It was concluded that the failure of the specific transducer does not represent a systemic risk associated with the design, age or use of this model of transducer.
Additional Manufacturer Narrative
An addendum report is being submitted to provide the date received by manufacturer with the philips¿ become aware date.The information is in the g3 field.
Additional Manufacturer Narrative
H11: inadvertently omitted statement: as part of capa 5677695, it was identified that retrospective review activities were warranted for intracavity transducer damage if physically split, fractured, or contains sharp edges on the transducer, regardless of whether the device is in clinical use.Philips ultrasound is reporting this complaint as part of the retrospective review completed for intracavity transducer damage.

• Brand Name: AFFINITI 50
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: roxanne ramirez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 17363099
• Report Number: 3019216-2023-00104
• Device Sequence Number: 20140630
• Product Code: IYN
• UDI-Device Identifier: 00884838056244
• UDI-Public: (01)00884838056244(21)USO18D1761
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K132304
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/02/2025

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: 989605410251
• Device Catalogue Number: 795208
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 07/06/2023; 05/02/2025
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 04/23/2024; 09/05/2024; 05/02/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown