MAUDE Adverse Event Report: SITE-RITE 8 ULTRASOUND SYSTEM CONSOLE (REMANUFACTURED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	9770600X
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
Event or Problem Description
Per tm - unit is giving a very grainy image.
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 the information, the following was concluded: the device was returned to the service facility.During the evaluation, the reported issue of grainy image was confirmed.The probe included with the scanner appeared to have cracks in the cabling leading up to the probe, also the cabling at the connector end appeared to be worn.Cue probe appears to be causing the grainy image issue, a known good probe was swapped out and the issue went away.The root cause of the reported issue is a use-related, internal failure in the cue probe.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
Per tm - unit is giving a very grainy image.

• Brand Name: SITE-RITE 8 ULTRASOUND SYSTEM CONSOLE (REMANUFACTURED)
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 12416291
• Report Number: 3006260740-2021-03669
• Device Sequence Number: 14331807
• Product Code: IYO
• UDI-Device Identifier: 00801741138270
• UDI-Public: (01)00801741138270
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K152554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

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: 9770600X
• Device Catalogue Number: 9770600X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 10/01/2021
• 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