MAUDE Adverse Event Report: SITE~RITE 8 ULTRASOUND SYSTEM 20MM PINPOINT GT; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	9770602Y
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of poor image quality was confirmed; the probe's image shows two black lines running down vertically.The site rite 8 20mm gt probe was visually inspected upon receipt and was found to be in good physical condition.The root cause of the reported issue is a probe failure.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
Event or Problem Description
The probe's image shows two black lines running down vertically.

• Brand Name: SITE~RITE 8 ULTRASOUND SYSTEM 20MM PINPOINT GT
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 12340364
• Report Number: 3006260740-2021-03374
• Device Sequence Number: 4346015
• Product Code: IYO
• UDI-Device Identifier: 00801741138201
• UDI-Public: (01)00801741138201
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/13/2021

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: 9770602Y
• Device Catalogue Number: 9770602Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other