iDrive Ultra IDRVULTRA1Recalls & reported problems

Summary

The FDA's MAUDE database contains 388 adverse event reports that list this exact device (DI 10884521142794), received between Feb 5, 2016 and Jun 30, 2023 — classified as 27 injuries, 361 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (161 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 25 most recent of 388 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE DID NOT FIRE. THE TRIGGER WAS NOT ABLE TO BE SHOT. THE DEVICE WAS CHANGED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17241307 ↗
• InjurySep 2, 2022Entrapment of Device; Failure to Calibrate; Misfire; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Failure to Calibrate; Misfire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION, IN THE MIDDLE OF A RECTAL RESECTION AFTER FINISHING THE DETACHMENT AROUND THE RECTUM, THE DEVICE PARTIALLY FIRED AND THE JAWS COULD NOT BE OPENED. THE HANDLE AND BATTERY WERE REPLACED, BUT THE CALIBRATION DID NOT GO WELL. A MANUAL ADAPTER TOOL WAS USED, BUT THE JAWS WOULD STILL NOT OPEN AND THE KNIFE DID NOT RETURN. IT WAS ALSO NOTED THAT THE ARTICULATION PART OF CARTRIDGE WAS DAMAGED AND A COMPONENT FELL INTO THE PATIENT'S CAVITY. THE RELOAD REMAINED ARTICULATED, THUS THE RELOAD COULD NOT BE REMOVED FORM THE ADAPTER AND COULD NOT BE REMOVED FROM THE TROCAR. THE INVOLVED TROCAR WAS USED WITHOUT ANY MALFUNCTION. THE SURGEON CONVERTED THE SURGERY INTO AN OPEN SURGERY, EXTENDED THE INCISION FOR MORE THAN 1 INCH, USED FORCEPS TO CLAMP AND TAKE OUT THE COMPONENT AND CUT CLOSER TO THE ANUS USING A MANUAL HANDLE TO REMOVE THE DEVICE. A CIRCULAR STAPLING DEVICE WAS THEN USED TO COMPLETE THE ANASTOMOSIS. THIS LED TO TISSUE LOSS AND OVER 30 MINUTES EXTENDED SURGICAL TIME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15349853 ↗
• MalfunctionMay 18, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE PROCEDURE, THE DEVICE DID NOT FIRE AND WAS DIFFICULT TO UNLOAD WITHOUT THE STAPLING FORCE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14431602 ↗
• MalfunctionFeb 8, 2022Failure to Read Input Signal; Failure to Fire; Failure to Read Input Signal; Failure to Fire

  ACCORDING TO THE REPORTER PRIOR USE OF THE DEVICE TO A PROCEDURE, THE HANDLE WAS NOT ABLE TO RECOGNIZE THE RELOAD. TO RESOLVE THE ISSUE, THE SURGEON REPLACED THE HANDLE. THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480124 ↗
• MalfunctionJan 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, BEFORE USING THE DEVICE ON THE STOMACH IN A CLOSE GASTROPLASTY PROCEDURE, THE COMPONENT OF THE DEVICE DISENGAGED. THE DEVICE WAS REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13154469 ↗
• MalfunctionNov 29, 2021Entrapment of Device; Misfire; Entrapment of Device; Misfire

  ACCORDING TO THE REPORTER DURING AN OPEN DISTAL GASTRECTOMY PROCEDURE, WHEN RESECTING THE STOMACH, FIRING WAS PERFORMED BUT IT STOPPED MIDWAY, COMPRESSION WAS ADVANCED, BUT IT DID NOT ADVANCE. IT WAS ALSO REPORTED THAT THE JAWS OF THE DEVICE LOCKED ON TISSUE. THERE WAS ALSO A TIME THAT LOADING THE CARTRIDGE TO THE ADAPTER WAS NOT POSSIBLE. TO FIX THE ISSUE, THE JAWS WERE REMOVED USING A MANUAL ADAPTER TOOL AND THE FIRING WAS PERFORMED TO FIX THE STAPLE LINE. THE BATTERY WAS ALSO REINSERTED AND RELOADED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12881836 ↗
• MalfunctionOct 6, 2021Misfire; Misfire

  ACCORDING TO THE REPORTER, IN A ROBOTIC LAPAROSCOPIC PARTIAL COLLECTION, THE FIRING WAS NOT FINISHED. SURGEON REPLACED THE DEVICE WITH A MANUAL STAPLER. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12584823 ↗
• MalfunctionSep 20, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ROUX-EN-Y OF GASTRIC POUCH, THE FIRST RELOAD WAS NOT POSSIBLE TO FIRE. A NEW RELOAD WAS USED HOWEVER, IT ONLY FIRE PARTIALLY TOGETHER WITH THE SECOND HANDLE AND ADAPTER. THE SECOND HANDLE AND ADAPTER WAS ABLE TO FIRE AND USED WITH THE 3RD RELOAD AND UNTIL THE END OF THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12495122 ↗
• MalfunctionAug 6, 2021Failure to Fire; Component or Accessory Incompatibility; Difficult to Open or Close; Failure to Fire; Component or Accessory Incompatibility; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING BARIATRIC SURGERY, THERE WAS PROBLEM LOADING THE DEVICE. THE HANDLE WAS NOT ABLE TO RECOGNIZE THE RELOAD AND THERE WAS PROBLEM LOADING THE RELOAD ONTO THE ADAPTOR EVEN IT WAS EXCHANGED FOR ANOTHER ONE; IT STILL DID NOT WORK. THE SURGEON WAS NOT ABLE TO PRESS THE GREEN BUTTON AND THE STAPLER DID NOT FIRE. IT WAS ALSO NOTED THAT THE JAWS OF THE DEVICE LOCKED ON TISSUE AND THE DOCTOR MANAGED TO UNLOCK AND REMOVE IT, REPLACING THE COMPLETE KIT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12287720 ↗
• MalfunctionJul 29, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTROPLASTY, THE DEVICE DID NOT FIRE. THE RELOAD WAS LOCKED. THE POWER HANDLE WAS REPLACED WITH ANOTHER AND THE SAME RELOAD WAS USED, BUT THE DEVICE ALSO GOT LOCKED. TO RESOLVE THE ISSUE, A NEW RELOAD AND STAPLER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249816 ↗
• MalfunctionJul 22, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY, 3 CARTRIDGES COULD BE USED NORMALLY, THE FOURTH ONE WAS CONNECTED TO THE ADAPTER AND TISSUE WAS CLAMPED, BUT AFTER THAT FIRING COULD NOT BE PERFORMED. IT COULD BE RELEASED FROM THE TISSUE, AND WHEN LOOKING AT THE HANDLE, IT ILLUMINATED IN A WAY SIMILAR TO THE ONE IN WHICH OF THE ADAPTER END OF LIFE, BUT IT WAS UNCERTAIN WHETHER IT REALLY ILLUMINATED IN THAT WAY. ANOTHER TYPE OF POWERED HANDLE WAS TAKEN OUT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214575 ↗
• MalfunctionJul 5, 2021Device Displays Incorrect Message; Difficult to Open or Close; Device Displays Incorrect Message; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC DISTAL GASTRECTOMY, THE TISSUE WAS CLAMPED BY THE STAPLER IN AN ATTEMPT TO RESECT THE TISSUE, BUT WHEN THE ANGLE WAS ADJUSTED AND AN ATTEMPT TO CLAMP THE TISSUE AGAIN WAS MADE, THE JAWS OF THE STAPLER REMAINED CLOSED AND COULD NOT BE OPENED. WHEN CHECKING THE LIGHTS, ALL 5 WHITE LIGHTS ILLUMINATED, THE STATUS INDICATOR ILLUMINATED BLUE, AND THE INDICATOR FOR THE POWER HANDLE SOMETIMES FLASHED GREEN AND SOMETIMES NOT. THE INDICATOR FOR THE ADAPTER ALSO SOMETIMES FLASHED GREEN AND SOMETIMES NOT. SOMETIMES THE LOADING OF THE ADAPTER WAS RECOGNIZED AND SOMETIMES NOT. THE DEVICE WAS RESTARTED BY TAKING OUT AND INSERTING THE BATTERY AGAIN AND WAS USED WITH NO FURTHER ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12119322 ↗
• MalfunctionJun 24, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, THE DEVICE WAS DEFECTIVE AND DID NOT FIRE WHEN USED DURING GASTROPLASTY. THE WHOLE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12060683 ↗
• MalfunctionJun 10, 2021Device Displays Incorrect Message; Failure to Fire; Device Displays Incorrect Message; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY, THE POWERED STAPLER WAS SET AND INSERTED THE INTESTINAL TRACT INTO THE JAWS OF THE REPORTED PRODUCT CARTRIDGE, THEN CLOSED THE JAWS, AND PRESSED THE GREEN BUTTON AND THE BLUE PUSH BUTTON, BUT THE SITUATION THAT THE STAPLING DID NOT ADVANCE WAS FOUND. IT WAS ALSO NOTED THAT THE STATUS INDICATOR ILLUMINATED IN BLUE IMMEDIATELY AFTER ATTACHMENT OF THE ADAPTER. THEREFORE, IN THAT CASE, THE POWERED STAPLER WAS STOPPED TO BE USED AND THE MANUAL HANDLE IN THE HOSPITAL WAS USED TO COMPLETED THE CASE. AT A LATER DATE, INSERTED THE BATTERY INTO THE POWERED HANDLE AND ATTACHED THE ADAPTER, BUT THE INDICATOR LAMP ABNORMALITY WAS FOUND. THE TROUBLE IN THE FIRST CASE AFTER REPLACING THE HANDLE AND THE ADAPTER WAS FOUND. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11979961 ↗
• InjuryMay 4, 2021Entrapment of Device; Insufficient Device Problem Information; Entrapment of Device; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LOW ANTERIOR RESECTION, WHILE STAPLING THE DISTAL RECTUM, THE STAPLER WAS FIRED BUT HAD AN INCOMPLETE STAPLE LINE ON THE PROXIMAL PART. THERE WAS ALSO POOR STAPLE FORMATION. AS A RESULT, THE RECTAL WAS OPENED AND CAUSED PELVIC CONTAMINATION. IN ADDITION, THE DEVICE JAWS LOCKED ON TISSUE AND WERE REMOVED BY PRESSING THE GREY BUTTON UNTIL THE JAWS OPENED. THE SURGERY WAS CONVERTED TO OPEN. MORE RELOADS AND A MANUAL STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS TISSUE DAMAGE AS A RESULT OF THE EVENT. SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE AS A RESULT OF THE EVENT. PATIENT HOSPITALIZATION WAS EXTENDED FOR ONE WEEK. THE PATIENT PROGRESSED TO DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Sepsis; Unspecified Tissue Injury

  MAUDE report 11772428 ↗
• MalfunctionMar 9, 2021Component or Accessory Incompatibility; Detachment of Device or Device Component; Component or Accessory Incompatibility; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE HANDLE AND THE RELOAD COULD NOT BE CONNECTED. THE CONNECTION PART OF THE HANDLE AND ADAPTER HAS BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449298 ↗
• MalfunctionDec 14, 2020Device Displays Incorrect Message; Failure to Fire; Device Displays Incorrect Message; Failure to Fire

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS BEING APPLIED TO THE STOMACH DURING A LAPAROSCOPIC GASTROPLASTY, THE DEVICE DID NOT FIRE AND TURNED ON A RED LIGHT. ANOTHER HANDLE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11004150 ↗
• MalfunctionOct 28, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHILE CUTTING VESSEL DURING LAPAROSCOPIC WHIPPLE SURGERY, THE SURGEON PRESSED THE FIRE BUTTON AFTER PRESSING THE SAFETY BUTTON, BUT THE STAPLE WAS NOT FIRED. THE SURGEON HAD TO REPLACE WITH MANUAL HANDLE AND NEW RELOAD TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10746520 ↗
• MalfunctionOct 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SERVICING, AFTER NORMAL HIGH TEMPERATURE AND HIGH-PRESSURE DISINFECTION, THE ADAPTER LOADING RING ON THE HANDLE FELL OFF. THE PRODUCT WAS BACK AND NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10611796 ↗
• MalfunctionSep 28, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING SERVICING, WHILE ON HANDS-ON TRAINING OF THE OPERATING ROOM NURSES, THE GRAY TOGGLE BUTTON FOR FIRING BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10593468 ↗
• MalfunctionSep 18, 2020Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, THE BLUE AND SILVER BUTTONS CAN BE PUSHED, BUT NOTHING HAPPENED. SO, THE LOAD OPEN AND CLOSE FUNCTION DID NOT WORK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10552555 ↗
• MalfunctionSep 17, 2020Device Displays Incorrect Message; Failure to Fire; Device Displays Incorrect Message; Failure to Fire

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE DID NOT FIRE AND THEN SHOWED A BLUE LIGHT. THE HANDLE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10545230 ↗
• InjurySep 10, 2020Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING THORACIC SURGERY ON A SEGMENTECTOMY PULMONARY, THE DEVICE LOCKED ON TISSUE. A COMPONENT BETWEEN THE ROD AND RELOAD BROKE OFF. A MANUAL STAPLER WAS USED TO RESECT THE TISSUE TO RELEASE THE RELOAD. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO DEVICE PROBLEM.

  Patient problems: No Code Available; Tissue Damage; Unspecified Tissue Injury

  MAUDE report 10518314 ↗
• MalfunctionAug 25, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE POWERED STAPLE DID NOT FIRE. A DISPOSABLE STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10447428 ↗
• MalfunctionJul 25, 2020Break; Component or Accessory Incompatibility; Break; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING DEVICE FOLLOW UP, THERE WAS PROBLEM LOADING THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10324310 ↗