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

Model Number	9770602X
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received by the manufacturer for evaluation.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
Event or Problem Description
Per biomed, they believe there is a cracked crystal due to the lines in the image and poor image quality.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.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 lines in the image and poor image quality was confirmed; there are black vertical lines showing on the display.The root cause of the reported failure was identified as a probe failure.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.
Event or Problem Description
Per biomed, they believe there is a cracked crystal due to the lines in the image and poor image quality.

• Brand Name: SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 10764670
• Report Number: 3006260740-2020-20316
• Device Sequence Number: 17187972
• Product Code: IYO
• UDI-Device Identifier: 00801741138195
• UDI-Public: (01)00801741138195
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 03/02/2021

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: 9770602X
• Device Catalogue Number: 9770602X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 03/25/2021
• 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