Site-Rite 9001C0197Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741037801), received between Oct 25, 2016 and Jun 16, 2021 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Defective Component” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2021Defective Component; Defective Component

  IT WAS REPORTED THAT TWO PROBE COVERS WERE NOTED TO BE REALLY THIN AND SPLIT AT THE END OF THE PROBE DURING PROCEDURES. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST PROBE COVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12008612 ↗
• MalfunctionJun 16, 2021Defective Component; Defective Component

  IT WAS REPORTED THAT TWO PROBE COVERS WERE NOTED TO BE REALLY THIN AND SPLIT AT THE END OF THE PROBE DURING PROCEDURES. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND PROBE COVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12008609 ↗
• MalfunctionOct 11, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT ONCE THE COVER WAS FITTED UPON THE PROBE OF THE ULTRASOUND, IT WAS NOTED A HOLE IN THE PROBE WHERE THE GEL WAS LEAKING OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9179747 ↗
• MalfunctionSep 13, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT ONCE INSERTED THE COVER UPON THE PROBE OF THE ULTRASOUND, THE COVER OPENED CAUSING LOSS OF STERILITY. IT APPEARS A LONGITUDINAL HOLE IN THE BAG FOLLOWING THE WELDING OF THE PLASTIC. TWO PROBE COVERS WERE RETURNED. THIS REPORT ADDRESSES THE SECOND PROBE COVER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9036130 ↗
• MalfunctionAug 21, 2019Material Puncture/Hole; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ONCE INSERTED THE COVER UPON THE PROBE OF THE ULTRASOUND, THE COVER OPENED CAUSING LOSS OF STERILITY. IT APPEARS A LONGITUDINAL HOLE IN THE BAG FOLLOWING THE WELDING OF THE PLASTIC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8917677 ↗
• MalfunctionJun 6, 2018Hole In Material

  IT WAS REPORTED THAT PROBE COVER WAS FOUND TO HAVE TWO HOLES IN THE BOTTOM AT THE END OF THE SURGICAL CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7573794 ↗
• MalfunctionJul 26, 2017Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT ON (B)(6) 2017 THE PROBE COVER KIT WITH GEL WAS OPENED FOR THE PROCEDURE. A BLACK HAIR WAS IDENTIFIED INSIDE THE PROBE COVER. THE PRODUCT WAS NOT USED ON THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6745393 ↗
• InjuryJul 19, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POTENTIAL CONTAMINATION MAY HAVE OCCURRED UPON ULTRASOUND PROCEDURE USING ULTRASOUND GEL PROVIDED IN THE PRODUCT. THE PATIENT WAS ADMITTED TO HOSPITAL WITH SEVERE MULTI LOBAR PNEUMONIA AND A LARGE LEFT SIDED PLEURAL EFFUSION. THE PLEURAL EFFUSION DRAINED UNDER ULTRASOUND GUIDANCE CONSISTED BURKHOLDERIA AND STREPTOCOCCUS MILLERI SPECIES. THE PATIENT ADMITTED TO INJECTING MORPHINE TABLETS MIXED WITH TAP WATER INTRAVENOUSLY BEFORE BECOMING SICK. THE HEALTH CARE PROFESSIONAL (HCP) COMMENTED ON THE POSSIBILITY THAT INJECTION OF TAP WATER BY THE PATIENT MAY HAVE CONTRIBUTED TO THIS INCIDENT. THE MICROBIOLOGIST TESTED THE ULTRASOUND GEL AND FOUND NO EVIDENCE OF CONTAMINATION.

  Patient problems: Bacterial Infection; Pleural Effusion; Pneumonia

  MAUDE report 6724703 ↗
• MalfunctionOct 25, 2016Hole In Material; Device Contamination With Biological Material

  ON 10/7/16 - FACILITY REPORTED THAT DURING A SURGICAL PROCEDURE THE PHYSICIAN WAS USING THE PROBE. WHEN REMOVED FROM PATIENT, THE PHYSICIAN NOTICED THAT THERE WAS BLOOD ON THE INSIDE OF THE PROBE COVER. THE HEALTHCARE PROFESSIONAL ALLEGES A HOLE IN THE PROBE COVER. SAMPLE WILL BE RETURNED FOR EVALUATION. ON 10/20/2016 - FACILITY REPORTS THE PROBE COVER WAS USED ON A GEIGER COUNTER HAND PIECE WHICH WAS USED DURING A BREAST NODE SURGERY. THEY STATE "THERE WAS NOTHING PRIOR TO USE" IN RESPONSE TO OUR QUESTION ASKING IF THE PATIENT HAD ANY BLEEDING PRIOR TO THE PROCEDURE THAT MAY HAVE TRANSFERRED TO THE PROBE COVER. THE FACILITY CONFIRMS THE SURGERY WAS AN OPEN CASE. .

  Patient problems: No Information

  MAUDE report 6054981 ↗