iDrive Ultra IDRVULTRA2Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10884521510579), received between Mar 11, 2016 and Sep 8, 2021 — classified as 7 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (20 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 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A SLEEVE GASTRECTOMY, THE HANDLE RECOGNIZED THE ADAPTER AND RELOAD, BUT THE TWO RELOADS WERE LOCKED AND NO LINES OF STAPLES CAME OUT AND DID NOT CUT. IT WAS NOTED THE RELOADS CANNOT BE USED AGAIN. THERE WAS NO ISSUE NOTED ON THE BATTERY. A MANUAL HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12440636 ↗
• MalfunctionMay 11, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRIOR TO USE, HANDLE WORKS VERY WELL TILL THE RELOAD WAS LOAD ON ADAPTER. BEFORE FIRING, WHEN THE GREEN BUTTON WAS PRESS, THERE WAS NO ANY FLASHING OF LIGHT AND STAPLER WAS UNABLE TO FIRE THE RELOAD. AFTER CLOSING JAW OF RELOAD AND BEFORE FIRING, WHEN PUSHING THE GREEN BUTTON, THERE WAS NOT ANY LIGHT BLINKING ON HANDLE AND STAPLER WAS NOT ABLE TO FIRE. REPLACEMENT FOR HANDLE WAS REQUESTED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805576 ↗
• MalfunctionMar 30, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC BARIATRIC SURGERY, THREE HANDLES AND THREE RELOADS WERE NOT ABLE TO FIRE BECAUSE THESE WERE PRE-SHOOTING. THE SECOND HANDLE HAD JAWS LOCKED ON THE TISSUE. A MANUAL STAPLER WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11587156 ↗
• MalfunctionMar 30, 2021Entrapment of Device; Failure to Fire; Entrapment of Device; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC BARIATRIC SURGERY, THREE HANDLES AND THREE RELOADS WERE NOT ABLE TO FIRE BECAUSE THESE WERE PRE-SHOOTING. THE SECOND HANDLE HAD JAWS LOCKED ON THE TISSUE. A MANUAL STAPLER WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11587152 ↗
• MalfunctionMar 30, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC BARIATRIC SURGERY, THREE HANDLES AND THREE RELOADS WERE NOT ABLE TO FIRE BECAUSE THESE WERE PRE-SHOOTING. THE SECOND HANDLE HAD JAWS LOCKED ON THE TISSUE. A MANUAL STAPLER WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11587149 ↗
• InjuryFeb 25, 2021Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE CUTTING ASSEMBLY SYSTEM DRAGGED THE TISSUE. THE JAWS LOCKED ON THE TISSUE. THE TISSUE WAS DAMAGED, SO THE SURGEON DISSECTED THE INJURED AND SUBSEQUENTLY CAUTERIZED TO AVOID BLEEDING.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11377623 ↗
• InjuryFeb 9, 2021Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING LOW ANTERIOR RESECTION, UPON COLON RESECTION, THERE WAS POOR STAPLE FORMATION. STAPLER WAS NOT ABLE TO FIRE ALL STAPLES COMPLETELY THAT THE STAPLE LINE WAS INCOMPLETE IN PROXIMAL. ANOTHER COMPETITIVE STAPLER WAS USED FOR RESECTION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11300127 ↗
• MalfunctionJan 6, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHILE BEING APPLIED TO ANASTOMOSES DUODENUM AND STOMACH ON A LAPAROSCOPIC SUBTOTAL GASTRECTOMY, THE DEVICE DID NOT FIRE. THE SAME EVENT OCCURRED TWICE ON THE RELOAD. A MANUAL HANDLE AND ANOTHER RELOAD WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11123547 ↗
• MalfunctionJan 5, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC WHIPPLE PROCEDURE, DURING DUODENUM RESECTION, THE SURGEON WAS ABLE TO PRESS THE GREEN AND SQUEEZE THE HANDLE BUT THE DEVICE DID NOT FIRE. THE SAME ISSUE OCCURRED WITH ANOTHER RELOAD. A MANUAL STAPLER AND A NEW RELOAD WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11118073 ↗
• InjuryJul 22, 2020Misfire; Misfire

  ACCORDING TO THE REPORTER, ON AN OPEN PROCEDURE, WHILE DISSECTING THE SIGMOID COLON, THE RELOAD ONLY FIRED UNTIL 10MM THEN STOPPED FIRING FURTHER. THE SURGEON REMOVED THE RELOAD THEN PERFORMED ANASTOMOSIS THROUGH SUTURING. THE SURGICAL TIME WAS EXTENDED FOR 2.5 HOURS AS THE SURGEON HAD TO CLEAN THE COLON AND PERFORM THE MANUAL ANASTOMOSIS.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 10309927 ↗
• MalfunctionMar 4, 2020Failure to Read Input Signal; Unintended Movement; Noise, Audible; No Visual Prompts/Feedback; Failure to Read Input Signal; Unintended Movement; Noise, Audible; No Visual Prompts/Feedback

  ACCORDING TO THE REPORTER, PRIOR TO LOW ANTERIOR RESECTION, DURING SET UP OF THE DEVICE, THERE WAS NO LIGHT WHEN LOADING THE RELOAD, AND THE SYSTEM WAS NOT REACTING WHEN PUSHING THE CLOSE BUTTON. ANOTHER RELOAD WAS USED FOR TESTING, AND THE SOUND DURING SET UP WAS STRANGE. WHEN THE LOADING UNIT WAS CONNECTED, IT STARTED TO MOVE AND ROTATE WITHOUT TOUCHING THE ROTATE BUTTON. SURGEON USED MANUAL STAPLER TO CONTINUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9785294 ↗
• MalfunctionJan 27, 2020Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, WHEN STAPLING THE STOMACH DURING A LAPAROSCOPIC GASTRIC BYPASS, THE HANDLE WAS ABLE TO RECOGNIZE THE RELOAD AND WAS BALE TO FIRE BUT HAD AN UNLOADING PROBLEM. IT WAS ALSO STATED THAT THE JAWS OF THE DEVICE LOCKED ON TISSUE. THE ADAPTER HAS BEEN DISCONNECTED AND RECONNECTED IN ORDER TO OPEN THE JAWS AND RETRIEVE THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9634973 ↗
• MalfunctionNov 4, 2019Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING THORACOTOMY, THE DEVICE WOULD NOT FIRE AS AFTER ARTICULATING THE RELOAD, IT WOULD NOT TURN BACK. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Information

  MAUDE report 9273408 ↗
• MalfunctionAug 29, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, ON THE FIRST FIRING AFTER THE JAWS OF THE DEVICE WAS CLAMPED ON THE TISSUE AND THE GREEN BUTTON WAS PRESSED, THE SURGEON THAT TO FIRE THE DEVICE BUT IT FAILED AND THE DEVICE DID NOT FIRE. THE PRODUCT STATUS BECAME PRE-FIRED. THE PROCEDURE WAS COMPLETED WITH MANUAL HANDLE WITHOUT ANY ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8946522 ↗
• MalfunctionJan 9, 2019Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, WHILE THE DEVICE WAS BEING APPLIED TO THE STOMACH, THE DEVICE STOPPED FIRING THE REINFORCED RELOAD AFTER ONCE CENTIMETER. THERE WAS AN INCOMPLETE STAPLE LINE PROXIMALLY. THE STAPLE LINE WAS FIXED NORMALLY USING NEW RELOAD. THEY CUT THE REINFORCEMENT RELOAD AND THEY USED MANUAL STAPLER TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8230964 ↗
• InjuryDec 27, 2018Misfire; Mechanics Altered; Misfire; Mechanics Altered

  ACCORDING TO THE REPORTER DURING LAPAROTOMY AT THE LOWER ANTERIOR RESECTION OF THE RECTUM BY LAPAROSCOPY, THE DEVICE CUT THE TISSUE BUT DID NOT STAPLE. THE STAPLE LINE IS ALSO INCOMPLETE AT THE DISTAL PART. THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE DUE TO DEVICE PROBLEM AND NEW STAPLE WAS USED TO COMPLETE THE CASE. THE PATIENT STAYED IN HOSPITAL FOR 6 DAYS INSTEAD OF 3-4 DAYS DUE TO THE DEVICE ISSUE. THE PROCEDURE WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO DEVICE ISSUE. THE INCISION WAS EXTENDED BY MORE THAN ONE INCH.

  Patient problems: No Code Available

  MAUDE report 8199940 ↗
• MalfunctionNov 15, 2018Misfire; Misfire

  ACCORDING TO THE REPORTER, THE EVENT OCCURRED BEFORE THE FIRST FIRING IN LAPARO HEPATECTOMY. EVEN THOUGH THE SURGEON TRIED STAPLING, THERE WAS A POSSIBILITY THAT ADAPTIVE FIRING TECHNOLOGY OPERATED DUE TO THE THICKNESS OF THE TISSUE AND THE STAPLING STOPPED. THE FIRING STOPPED HALFWAY. NEW RELOAD WAS USED FOR THE SAME TISSUE AND THE STAPLING WAS COMPLETED WITHOUT PROBLEMS. THE STATUS OF THE PATIENT WAS REPORTED AS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8073220 ↗
• MalfunctionOct 5, 2018Misfire; Misfire

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE POWERED STAPLER WAS UNABLE TO FIRE THE RELOAD LEADING TO AN INCOMPLETE DISTAL STAPLE LINE. IT WAS A PRESENTATION SO IT WAS UNNECESSARY TO FIX THE STAPLE LINE. THE JAWS WERE ARTICULATED AND THEY DID THREE ATTEMPTS WITH THREE DIFFERENT RELOADS BUT WERE UNSUCCESSFUL. AFTER APPLYING 1CM IT STOPPED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7939008 ↗
• MalfunctionSep 25, 2018Device Displays Incorrect Message; Failure to Fire; Device Displays Incorrect Message; Failure to Fire

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE STAPLER WAS NOT ABLE TO FIRE. THE HANDLE ONLY HAD BLUE LIGHT ON AND THEY TRIED THREE BATTERIES THAT WERE COMPLETELY CHARGED THAT WORKED PERFECTLY WELL WITH ANOTHER HANDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7905703 ↗
• MalfunctionAug 24, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LOBECTOMY PULMONARY VASCULATURE, THE RELOAD PLACED ON TISSUE AND CLOSED IT BUT THE SURGEON WAS UNABLE TO PRESS THE GREEN BUTTON AND THE DEVICE DID NOT FIRE. THIS HAPPENED WITH THE SECOND BLACK RELOAD. A NEW HANDLE AND RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7812929 ↗
• MalfunctionAug 17, 2018Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, ON FIRST FIRING OF STAPLER ON THE STOMACH, THE STAPLE LINE WAS INCOMPLETE CENTRALLY. ANOTHER RELOAD WAS PLACED ON THE SAME HANDLE AND FINISHED THE STAPLE LINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7793340 ↗
• MalfunctionJul 30, 2018Unintended System Motion; Failure to Form Staple; Unintended System Motion

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS APPLIED TO THE STOMACH ON A ROBOTIC LAPAROSCOPIC GASTRIC BYPASS, THE STAPLER WOULD STRAIGHTEN OUT AND LOSE POSITION EVERY TIME THE SURGEON WOULD TRY TO CLOSE THE STAPLER IN THE ARTICULATED (TO THE LEFT) POSITION. THEY REPLACED THE FAILED STAPLE LOAD WITH AN IDENTICAL LOAD FROM THE SAME BOX TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7732599 ↗
• MalfunctionJun 27, 2018Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING GASTRIC SLEEVE LAPAROSCOPY, THE STAPLER BEGAN TO FIRE AND STOPPED ON TISSUE ON THE STOMACH THAT SHOULD NOT HAVE BEEN TOO THICK. THEY OPENED A LAPAROSCOPIC HANDLE TO RESOLVE THE ISSUE AND CONTINUED THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7641732 ↗
• InjuryJun 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVE A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, AT FIRST THE STAPLE LINES LOOKED FINE THEN THE PATIENT BEGAN TO BLEED AND VOMIT. THERE WAS POOR STAPLE FORMATION WHICH LED TO BLOOD LOSS OF 500CC OR MORE AND BLOOD TRANSFUSION WAS REQUIRED. AN ADDITIONAL OPERATION WILL BE PERFORMED TO CORRECT THE ISSUE. THE PATIENT HAD PROLONGED HOSPITALIZATION AND WITH CONTROLLED BLEEDING AND TRANSFUSION PATIENT SHOULD RECOVER.

  Patient problems: Blood Loss; No Code Available; Vomiting

  MAUDE report 7629358 ↗
• MalfunctionJun 12, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC LOWER ANTERIOR RESECTION, ON THE RECTUM TISSUE, THE STAPLER WAS NOT ABLE TO FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE BUT THE JAWS OF THE DEVICE LOCK ON TISSUE AND WAS REMOVED BY OPENING IT. THE SURGICAL TIME WAS EXTENDED BY THIRTY MINUTES OR MORE AND THE SURGEON HAD TO SWITCH TO MANUAL GUN IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7591416 ↗