AutoSonix 012001Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10884521058163), received between Apr 26, 2016 and Aug 27, 2019 — classified as 43 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (23 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2019Mechanical Problem; Failure to Cut; Mechanical Problem; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LIVING DONOR NEPHRECTOMY, WHEN USING THE FIRST DEVICE FOR THE FIRST SEALING, THE DE VICE DID NOT GRASP WELL, SO THE SECOND DEVICE OPENED FOR USE. WHEN USING THE SECOND DEVICE, FROM THE MIDDLE OF USE, CUTTING BECAME UNABLE TO BE PERFORMED WELL, SO THE THIRD DEVICE WAS USED. AFTER THAT, THE PROCEDURE WAS COMPLETED WITHOUT PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8938352 ↗
• MalfunctionApr 11, 2019Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LIVING DONOR NEPHRECTOMY, UPON USING THE DEVICE, THE DEVICE WAS NOT ABLE TO CUT THE TISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8505864 ↗
• MalfunctionApr 11, 2019Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LIVING DONOR NEPHRECTOMY PROCEDURE, ENERGIZATION WAS UNABLE TO BE PERFORMED AND THE DEVICE COULD NOT CUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT WAS REPORTED AS NO PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8504720 ↗
• MalfunctionApr 11, 2019Break; Break

  ACCORDING TO THE REPORTER, WHEN WIPING THE TIP DURING A LAPAROSCOPIC NEPHRECTOMY, THE TIP BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8503518 ↗
• MalfunctionFeb 1, 2019Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LIVING DONOR NEPHRECTOMY PROCEDURE, THE SHARPNESS OF THE DEVICE BECAME WORSE/THE FORCE OF CLIPPING BECAME WEAK. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8296804 ↗
• MalfunctionOct 22, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LIVING DONOR NEPHRECTOMY, THE RUBBER PART AT THE TIP HAS PEELED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7990654 ↗
• MalfunctionOct 22, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LIVING DONOR NEPHRECTOMY, AT THE BEGINNING, THE PRODUCTS WERE ABLE TO BE USED BUT THEY WERE NOT ABLE TO USED IT WHILE USING THE DEVICE (NO RESPONSE), THE CONNECTION WITH THE TRANSDUCER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7990556 ↗
• MalfunctionOct 5, 2018Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LIVING DONOR NEPHRECTOMY, THE DEVICE DID NOT WORK NORMALLY AND THE TISSUE COULD NOT BE CUT. THEY USED ANOTHER PRODUCT TO CONTINUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7937999 ↗
• MalfunctionSep 5, 2018Material Protrusion/Extrusion; Material Protrusion/Extrusion

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LIVING DONOR NEPHRECTOMY, THE DEVICE WAS SHARPER THAN USUAL. THE TISSUE PAD WAS ABOUT TO FALL INTO THE PATIENT CAVITY, SO THE SURGEON STOPPED USING IT HALFWAY. A NEW DEVICE WAS USED TO CONTINUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7845781 ↗
• MalfunctionSep 4, 2018Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING THORASCOPIC LOBECTOMY, THE DEVICE WAS USED BUT IT COULD NOT CUT. A NEW DEVICE WAS USED TO CONTINUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7843096 ↗
• MalfunctionSep 4, 2018Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LIVING DONOR NEPHRECTOMY, THE DEVICE WAS USED BUT UNABLE TO CUT. THEY USED ANOTHER DEVICE TO CONTINUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7841938 ↗
• MalfunctionAug 21, 2018Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LIVING DONOR NEPHRECTOMY, IN THE MIDDLE OF USE, THE DEVICE COULD NOT CUT AT ALL EVEN IT WAS ACTIVATED. THEY USED ANOTHER DEVICE TO CONTINUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7801746 ↗
• MalfunctionMay 9, 2018Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LIVING DONOR NEPHRECTOMY PROCEDURE, AFTER DEVICE ACTIVATION, THE DEVICE SUDDENLY DID NOT CUT TISSUE. NEW DEVICE WAS OPENED TO CONTINUE. NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7498546 ↗
• MalfunctionApr 3, 2018Failure to Cut; Noise, Audible; Failure to Cut; Noise, Audible

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LIVING DONOR NEPHRECTOMY, METALLIC NOISE WAS HEARD WHILE IN USE, AND THE DEVICE DID NOT CUT TISSUE ANYMORE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7393876 ↗
• MalfunctionMar 21, 2018Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER DURING LAPAROSCOPIC LIVING DONOR NEPHRECTOMY, TISSUE WAS NOT CUT IN THE MIDDLE OF USE. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7360023 ↗
• MalfunctionMar 21, 2018Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER DURING LAPAROSCOPIC LIVING DONOR NEPHRECTOMY, THE DEVICE DID NOT CUT TISSUE SUDDENLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7360007 ↗
• MalfunctionMar 2, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LIVING DONOR NEPHRECTOMY, THE DEVICE CUT TISSUE POORLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7311188 ↗
• MalfunctionMar 2, 2018Failure to Cut; Noise, Audible; Failure to Cut; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LIVING DONOR NEPHRECTOMY PROCEDURE, NOISE WAS HEARD WHILE IN USE, AND TISSUE WAS NOT CUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7311182 ↗
• MalfunctionFeb 8, 2018Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LIVING DONOR NEPHRECTOMY, DEVICE DID NOT CUT. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7252199 ↗
• MalfunctionFeb 7, 2018Failure to Cut; Noise, Audible; Failure to Cut; Noise, Audible

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LIVING DONOR NEPHRECTOMY PROCEDURE, A NOISE WAS HEARD AND THE DEVICE DID NOT CUT. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7248923 ↗
• MalfunctionFeb 7, 2018Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LIVING DONOR NEPHRECTOMY PROCEDURE, THE DEVICE STARTED CUTTING TISSUE POORLY. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7247701 ↗
• MalfunctionJan 16, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC LIVING DONOR NEPHRECTOMY PROCEDURE. THE TISSUE PAD DISENGAGED FROM THE DEVICE WHILE IN USE. THE PIECE FELL INTO THE CAVITY AND COULD BE RETRIEVED. THE DEVICE WAS RECOGNIZED BY THE GENERATOR AND WAS ACTIVATED. A NEW DEVICE WAS USED TO CONTINUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7193854 ↗
• MalfunctionJan 15, 2018Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC LIVING DONOR NEPHRECTOMY PROCEDURE. THE DEVICE STARTED CUTTING THE TISSUE POORLY. EVENTUALLY THE TISSUE WAS NOT CUT AT ALL. THE DEVICE WAS RECOGNIZED BY THE GENERATOR AND WAS ACTIVATED. A NEW DEVICE WAS OPENED TO CONTINUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7189223 ↗
• MalfunctionDec 21, 2017Dull, Blunt; Dull, Blunt

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LIVING DONOR NEPHRECTOMY PROCEDURE, THE DEVICE STARTED CUTTING POORLY. A NEW DEVICE WAS USED TO CONTINUE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7140819 ↗
• MalfunctionDec 18, 2017Device Operates Differently Than Expected; Noise, Audible; Device Operates Differently Than Expected; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LIVING DONOR NEPHRECTOMY, THE DEVICE STARTED CUTTING THE TISSUE POORLY AND A STRANGE NOISE WAS HEARD. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7124405 ↗