Endo GIA EGIA30AVRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884521186095), received between Aug 7, 2017 and Jun 14, 2024 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (14 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Apr 26, 2018Class IITerminated

   Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

   Z-1822-2018 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LIVER RESECTION, AT THE TIME OF LIVER VESSELS RESECTION, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON; IT WAS STUCK. THEREFORE, THE RELOAD DID NOT CUT OR STAPLE. ANOTHER RELOAD WAS USE, BUT THE SAME ISSUE OCCURRED. A NEW HANDLE WAS USED WITH THE SAME 2ND RELOAD TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19539651 ↗
• MalfunctionMay 9, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NEPHRECTOMY PROCEDURE, WHEN THE SURGEON TRIED TO FIRE, THEY COULD PRESS THE GREEN BUTTON BUT COULD NOT SQUEEZE AND THE FIRING WAS UNABLE TO BE PERFORMED. SETTING UP WAS CARRIED OUT AGAIN BUT STILL IT COULD NOT BE USED. ALL THE DEVICES WERE REPLACED, AND THE SURGERY WAS CONTINUED. THE STATUS OF THE PATIENT WAS REPORTED AS NO PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8595637 ↗
• MalfunctionMay 6, 2019Break; Component or Accessory Incompatibility; Break; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER PRIOR TO A LOBECTOMY, WHEN THE HANDLE AND CARTRIDGE WERE CONNECTED, THE SLEEVE PART OF THE CARTRIDGE MISALIGNED AND COULD NOT BE CONNECTED TO THE HANDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8584390 ↗
• MalfunctionApr 24, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHILE THE DEVICE WAS BEING USED FOR PULMONARY BLOOD VESSEL TREATMENT DURING A LOBECTOMY, AFTER CLAMPING THE TISSUE, THE GREEN BUTTON WAS PRESSED TO TRY TO FIRE, BUT THE HANDLE WAS HARD AND COULD NOT BE SQUEEZED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8544006 ↗
• MalfunctionJan 9, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A VIDEO ASSISTED THORASCOPIC RIGHT UPPER LOBECTOMY PROCEDURE, THE GREEN BUTTON WAS PRESSED BUT WHEN THE HANDLE WAS BEING SQUEEZED, IT COULD NOT BE SQUEEZED FIRMLY. THE BLACK RETURN KNOB WAS PULLED AND THE DEVICE WAS RELEASED FROM THE TISSUE. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8231386 ↗
• MalfunctionSep 19, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE SECOND FIRING OF SEGMENTAL RESECTION OF LUNG AND THORACOSCOPY PROCEDURE, THE DEVICE COULD NOT BE FIRED EVEN AN OPENING AND CLOSING CHECK WAS DONE WITHOUT PROBLEM. A NEW DEVICE WAS USED TO COMPLETE THE FIRING WITHOUT ANY PROBLEMS. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7889688 ↗
• MalfunctionApr 18, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE FIRST FIRING OF THE DEVICE IN LAPAROSCOPIC NEPHRECTOMY PROCEDURE, THEY CONNECTED RELOAD TO THE HANDLE. THE SURGEON CLAMPED THE RENAL VEIN AND PUSHED THE GREEN BUTTON AND TRIED TO SQUEEZE THE HANDLE ,HOWEVER COULD NOT SQUEEZE IT. THEY REPLACED IT WITH A NEW RELOAD, AND THE SURGEON CLAMPED THE RENAL VEIN, HOWEVER THE SAME EVENT OCCURRED. THE SALES REP NOTED SOME STAPLES OF THE PROXIMAL END WERE PRE-FIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7439927 ↗
• MalfunctionApr 17, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACO/LOBECTOMY PROCEDURE, THE SURGEON APPROACHED A BLOOD VESSEL WITH THE DEVICE ONCE, BUT REMOVED IT WITHOUT FIRING DUE TO INSUFFICIENT DISSECTION OF THE VESSEL. THE DEVICE WAS LEFT IN THE CLEAN FIELD FOR LATER FIRING. AFTER THAT, THE RELOAD WAS LOADED ONTO THE HANDLE WITHOUT PROBLEM, BUT WHEN SURGEON TRIED TO FIRE THE DEVICE TO THE BLOOD VESSEL, IT COULD NOT FIRE. THE STATUS OF THE PATIENT WAS FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7436763 ↗
• InjuryMar 22, 2018Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING RIGHT UPPER LOBE RESECTION, THE SURGEON USED A STAPLER AT THE FIRST FIRING TO INTERLOBAR AND USED ANOTHER STAPLER AT THE SECOND FIRING TO PV WITH NO PROBLEM. AT THE THIRD FIRING TO A1+3, THE SURGEON USED ONE MORE DEVICE (DIFFERENT LOT NUMBER). DURING THE FIRING, HE DID NOT HAVE A FEEL OF STAPLING AT ALL. AFTER HE FULLY FIRED THE DEVICE, HE AND THE CARDIOVASCULAR SURGEON MANUALLY SUTURED THE BLEEDING SITE WITHOUT OPEN THE JAWS OF CARTRIDGE. BLOOD LOSS OF 7000CC WAS NOTED. THE PATIENT HAD RECEIVED BLOOD TRANSFUSION AS A RESULT OF THE ISSUE. HOWEVER THE PROCEDURE WAS COMPLETED WITH NO PROBLEM. THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE. THE PATIENT HOSPITALIZATION IS EXTENDED .THE PATIENT IS STAYING AT ICU AND UNDER MONITORING AND IN GOOD PROGRESS.

  Patient problems: Blood Loss; No Code Available; Tissue Damage

  MAUDE report 7362410 ↗
• MalfunctionDec 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER: OCCURRED DURING A LOBECTOMY. AFTER FIRING, THEY NOTICED BLEEDING FROM THE SECOND STAPLE LINE AT THE PULMONARY VEIN AND THE THIRD STAPLE LINE AT UPPER MIDDLE LOBE OF THE LUNG. THE BLEEDING WAS ARRESTED WITH AN ELECTROSURGICAL KNIFE AND WAS NOT MORE THAN 500CCS. NO AIR LEAK WAS CONFIRMED USING A LEAK TEST. SUBSEQUENT FIRINGS WITH DIFFERENT RELOADS WERE SUCCESSFUL. PATIENT STATUS IS ALIVE, NO INJURY.

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

  MAUDE report 7152236 ↗
• MalfunctionDec 19, 2017Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY, FOR THE FIRST FIRING FOR LOBECTOMY, THE NURSE CONNECTED RELOAD TO THE HANDLE AND CHECKED THE JAWS OPENING/CLOSING. THEN THE SURGEON CLAMPED THE VESSEL AND TRIED TO SQUEEZE THE HANDLE, HOWEVER THE HANDLE WAS STIFF AND COULD NOT FIRE THE DEVICE AT ALL. THE PROCEDURE WAS COMPLETED WITH ANOTHER. DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THE STATUS OF THE PATIENT IS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7130302 ↗
• MalfunctionDec 15, 2017Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER: OCCURRED DURING A THORACO/LOBECTOMY. DURING THE SECOND FIRING FOR RIGHT INFERIOR LOBE RESECTION, THE DEVICE COULD NOT BE FIRED. THE SURGEON COULD NOT SQUEEZE THE HANDLE. THE CASE WAS COMPLETED USING A NEW RELOAD. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7122880 ↗
• MalfunctionOct 25, 2017Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NEPHRECTOMY PROCEDURE, AT THE FIRST FIRING FOR RENAL VEIN RESECTION, THE SURGEON TRIED TO FIRE THE DEVICE, HOWEVER COULD NOT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT IS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6976414 ↗
• MalfunctionOct 24, 2017Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER: DURING THE 2ND FIRING FOR THORACO/LOBECTOMY, THE SURGEON TRIED TO FIRE THE DEVICE TO VESSEL, HOWEVER COULD NOT SQUEEZE THE HANDLE AT ALL. THE EVENT OCCURRED IN USE FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT: NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6973841 ↗
• MalfunctionOct 5, 2017Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, THE SURGEON COULD NOT FIRE THE DEVICE ON THE PULMONARY VEIN. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6918745 ↗
• MalfunctionAug 31, 2017Failure to Fire; Failure to Fire

  DURING A LOBECTOMY PROCEDURE, FOR THE THIRD FIRING FOR RIGHT INFERIOR LOBE RESECTION, THE SURGEON CLAMPED THE TISSUE OF PULMONARY ARTERY AND TRIED TO SQUEEZE THE HANDLE, HOWEVER IT WAS LOCKED AND COULD NOT FIRE THE DEVICE. REPLACED BY A NEW CARTRIDGE, THE FIRING WAS COMPLETED WITH NO PROBLEM. THE STATUS OF THE PATIENT IS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6833687 ↗
• MalfunctionAug 7, 2017Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER: DURING THORACO/LOBECTOMY, THEY CONNECTED CARTRIDGE TO HANDLE FOR THE THIRD FIRING FOR RESECTION OF RIGHT UPPER LOBE OF LUNG, THE SURGEON TRIED TO FIRE THE DEVICE, HOWEVER COULD NOT. REPLACED BY A NEW CARTRIDGE, THE PROCEDURE WAS COMPLETED WITH NO PROBLEM. THE STATUS OF THE PATIENT: NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6771627 ↗