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

Model Number 9770602X

Device Problems Crack (1135); Poor Quality Image (1408)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2020

Event Type  malfunction  

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 Description

Per biomed, they believe there is a cracked crystal due to the lines in the image and poor image quality.

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 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
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 10764670
• MDR Text Key: 215338563
• Report Number: 3006260740-2020-20316
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741138195
• UDI-Public: (01)00801741138195
• Combination Product (y/n): N
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 03/02/2021
• Supplement Dates FDA Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other