MAUDE Adverse Event Report: SITE~RITE 8 ULTRASOUND SYSTEM 32MM LINEAR PROBE REFURBISHED; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	9770601X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
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 damaged probe strain relief is confirmed.The cable has been pulled away from the strain relief boot cover which has the wires are now exposed.The root cause of the reported failure was identified as use-related.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 - cord pulling away from strain relief.07/27/2021 evaluation of the sample found the wires to be exposed.

• Brand Name: SITE~RITE 8 ULTRASOUND SYSTEM 32MM LINEAR PROBE REFURBISHED
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 12281148
• Report Number: 3006260740-2021-03173
• Device Sequence Number: 4494707
• Product Code: IYO
• UDI-Device Identifier: 00801741138300
• UDI-Public: (01)00801741138300
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 07/27/2021

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: 9770601X
• Device Catalogue Number: 9770601X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/05/2021
• 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