Acessa ProVu Transducer with sensor 7700Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00854763006188), received between Jul 3, 2019 and Jul 18, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2019Scratched Material; Scratched Material

  ON 6/20/2019, IT WAS REPORTED THAT ABOUT 75% THROUGH A CASE, THAT THE ACESSA PROVU TRANSDUCER WITH SENSOR (7700) WAS IDENTIFIED AS HAVING A SURFACE DEFECT ON THE SILICONE ACOUSTIC LENS OF THE TRANSDUCER. PRIOR TO THAT POINT IN THE CASE, NEITHER THE OPERATING PHYSICIAN NOR ANY MEMBER OF THE SURGICAL STAFF HAD OBSERVED ANY DAMAGE TO THE TRANSDUCER. UPON RECOGNITION OF THE DAMAGED SILICONE, THE CAVITY WAS SUCTIONED AND CLEARED TO ENSURE REMOVAL OF ANY POTENTIAL DEBRIS, WITH A STATEMENT OF CONFIDENCE FROM THE OPERATING PHYSICIAN STATING THAT THE CAVITY HAD BEEN APPROPRIATELY CLEARED. THE CASE WAS COMPLETED SUCCESSFULLY, THERE WAS NO REPORTED HARM, INJURY, ADVERSE OUTCOME, OR PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8804606 ↗
• MalfunctionJul 3, 2019Scratched Material; Scratched Material

  ON 6/7/2019, IT WAS REPORTED THAT DURING A CASE, THE ACESSA PROVU HANDPIECE (7300) MADE CONTACT WITH THE ACESSA PROVU TRANSDUCER WITH SENSOR'S (7700) ACOUSTIC LENS. THE OPERATING PHYSICIAN INADVERTENTLY MADE CONTACT BETWEEN THE DISTAL TIP OF THE HANDPIECE AND THE SILICONE LENS OF THE TRANSDUCER. THE CONTACT OF THE SHARP DISTAL MANDREL OF THE HANDPIECE WITH THE SILICONE SCANNING WINDOW RESULTED IN DAMAGE TO THE SILICONE LAYER OF THE LENS IN TWO SEPARATE LOCATIONS. UPON RECOGNITION OF THE DAMAGED SILICONE, THE CAVITY WAS SUCTIONED AND CLEARED TO ENSURE REMOVAL OF ANY POTENTIAL DEBRIS, WITH A STATEMENT OF CONFIDENCE FROM THE OPERATING PHYSICIAN STATING THAT THE CAVITY HAD BEEN APPROPRIATELY CLEARED. THE CASE WAS COMPLETED SUCCESSFULLY, THERE WAS NO REPORTED HARM, INJURY, ADVERSE OUTCOME, OR PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8761571 ↗