Reliamax GIA8038RLRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 20884521168630), received between Oct 18, 2017 and May 18, 2022 — classified as 1 death, 7 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2022Detachment of Device or Device Component; Fail-Safe Problem; Detachment of Device or Device Component; Fail-Safe Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN GASTRECTOMY, WHILE RESECTING THE STOMACH, A COMPONENT OF THE DEVICE DISENGAGED. THE WHITE INTERLOCK POP UP BEFORE LOADING INTO THE DEVICE. TO RESOLVE THE ISSUE, A NEW RELOAD WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14432223 ↗
• InjuryJan 5, 2021Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A HEMICOLECTOMY, THERE WAS POOR STAPLE FORMATION, THE STAPLE LINE WAS INCOMPLETE, THE USER OVERSEWED TO FIX THE ISSUE. ANOTHER CARTRIDGE WAS USED TO COMPLETE THE CASE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11115230 ↗
• MalfunctionDec 28, 2020Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING FIRING OF DEVICE ON TRANSVERSE COLON IN A HEMICOLECTOMY, ONE RELOAD FIRED PARTIALLY AND THE OTHER RELOAD GOT BROKEN. THE SURGEON REPLACED THE RELOAD TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11076566 ↗
• MalfunctionDec 28, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING FIRING OF DEVICE ON TRANSVERSE COLON IN A HEMICOLECTOMY, ONE RELOAD FIRED PARTIALLY AND THE OTHER RELOAD GOT BROKEN. THE SURGEON REPLACED THE RELOAD TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11076532 ↗
• MalfunctionNov 9, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN HEMICOLECTOMY, WHILE PERFORMING COLON TRANSECTION, THE DEVICE DID NOT FIRE, AND THE FIRING KNOB WAS STUCK. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10808870 ↗
• MalfunctionOct 29, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHEN PREPARING FOR AN OPEN COLECTOMY, THE BLACK PUSHER THUMB PIECE COULD NOT BE MOVED AT ALL AND THE DEVICE DID NOT FIRE. ANOTHER RELOAD WAS USED.

  Patient problems: Insufficient Information; No Information

  MAUDE report 10756076 ↗
• MalfunctionSep 30, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE RELOAD'S FIRING KNOB WAS BROKEN AND DISENGAGED WHILE TAKING IT OUT OF THE BOX. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 10605273 ↗
• MalfunctionJul 17, 2020Misfire; Misfire

  ACCORDING TO THE REPORTER, ON AN OPEN ESOPHAGECTOMY, WHILE MAKING THE POUCH IN THE STOMACH, THE SURGEON WAS ABLE TO FIRE HALF THE DEVICE AND NEEDED TO WITHDRAW DUE TO NOT BEING ABLE TO STAPLE FURTHER. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 10291407 ↗
• MalfunctionJul 17, 2020Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE FIRING KNOBS AS WELL AS CARTRIDGES WERE BROKEN. THE SAME EVENT OCCURRED ON FOUR UNITS OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 10291025 ↗
• MalfunctionJul 9, 2020Break; Component or Accessory Incompatibility; Break; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, WHEN THE NURSE WAS SETTING UP THE DEVICE FOR THE FIRST FIRING DURING A TOTAL PELVIC EXENTERATION PROCEDURE, THE KNIFE COVER WAS FOUND TO BE FUNCTIONAL AND THE CARTRIDGE COULDN'T BE COMBINED WITH THE STAPLER. IT WAS ALSO REPORTED THAT, THERE WAS A CRACK IN THE KEY PART OF THE KNIFE COVER. THE PROCEDURE WAS COMPLETED WITHOUT PROBLEMS BY USING A NEW CARTRIDGE. THE DEVICE WAS NOT USED IN THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10254902 ↗
• InjuryMar 10, 2020Misfire; Failure to Form Staple; Detachment of Device or Device Component; Fail-Safe Problem; Misfire; Failure to Form Staple; Detachment of Device or Device Component; Fail-Safe Problem

  ACCORDING TO THE REPORTER, DURING HEMICOLECTOMY WITH TOTAL ABDOMINAL HYSTERECTOMY AND SALPINGOOOPHORECTOMY, AFTER OPENING THE STERILE PACKAGING, YELLOW SHIPPING WEDGE WAS ALREADY REMOVED WITHOUT EVEN REMOVING IT MANUALLY. WHEN APPLIED ON THE ANASTOMOSIS, THE FIRING KNOB BROKE FOR THE WHITE FLAG INTERLOCK ALREADY ENGAGED. IT WAS ALSO REPORTED THAT DEVICE PARTIALLY FIRED AND HAD POOR STAPLE FORMATION WHICH STAPLES GOT DISMANTLED. MISFIRED STAPLES FELL INTO THE PATIENT CAVITY. SURGEON OVERSEWED TO FIX THE STAPLE LINE.

  Patient problems: No Code Available

  MAUDE report 9811995 ↗
• DeathFeb 26, 2020Loss of or Failure to Bond; Failure to Form Staple; Loss of or Failure to Bond; Failure to Form Staple

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, ON AN OPEN HEMICOLECTOMY, THE STAPLES HAD FAILED TO CLOSE THE STAPLE LINE AT THE COLON BECAUSE OF POOR STAPLE FORMATION. THE PATIENT WENT BACK FOR REOPERATION TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. HENCE, THERE WAS TISSUE DAMAGE. THE PATIENT DIED.

  Patient problems: Death; No Code Available; Tissue Damage

  MAUDE report 9759638 ↗
• InjuryJan 3, 2020Unsealed Device Packaging; Misfire; Detachment of Device or Device Component; Unsealed Device Packaging; Misfire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HEMICOLECTOMY PROCEDURE, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE BUT DEVICE MISFIRED AND THERE WAS POOR STAPLE FORMATION AND THE STAPLE LINE WAS INCOMPLETE. THE CASE WAS CONVERTED INTO AN OPEN PROCEDURE AND USED AN OPEN STAPLER TO COMPLETE THE CASE. THE FIRING KNOB OF THE OPEN STAPLER BROKE AND THE STAPLER PARTIALLY FIRED. THE STAPLE LINE WAS RESECTED AND RE-STAPLED. IT WAS ALSO NOTED THAT THERE WAS AN ISSUE WITH THE SEAL OF THE PACKAGING OF THE OPEN STAPLER. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 9545375 ↗
• InjuryNov 18, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING RIGHT HEMICOLECTOMY, AFTER THE DEVICE WAS FIRED AT THE THIRD FIRING (SIDE-TO-SIDE ANASTOMOSIS), WHEN THE ANASTOMOSED SITE WAS CHECKED, IT WAS FOUND TO BE NOT ANASTOMOSED SUCCESSFULLY AND THE STAPLES WERE NOT FORMED TO BE U-SHAPE. MANUAL SUTURING WAS PERFORMED TO RECOVER THE STAPLE LINE, AND ON THE ENTRY HOLE WITHOUT USING DEVICE.

  Patient problems: Failure to Anastomose; No Code Available

  MAUDE report 9335252 ↗
• InjuryNov 18, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING RIGHT HEMICOLECTOMY, AFTER THE DEVICE WAS FIRED AT THE THIRD FIRING (SIDE-TO-SIDE ANASTOMOSIS), WHEN THE ANASTOMOSED SITE WAS CHECKED, IT WAS FOUND TO BE NOT ANASTOMOSED SUCCESSFULLY AND THE STAPLES WERE NOT FORMED TO BE U-SHAPE. MANUAL SUTURING WAS PERFORMED TO RECOVER THE STAPLE LINE, AND ON THE ENTRY HOLE WITHOUT USING DEVICE.

  Patient problems: Failure to Anastomose; No Code Available

  MAUDE report 9335226 ↗
• InjuryNov 18, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING RIGHT HEMICOLECTOMY, AFTER THE DEVICE WAS FIRED AT THE THIRD FIRING (SIDE-TO-SIDE ANASTOMOSIS), WHEN THE ANASTOMOSED SITE WAS CHECKED, IT WAS FOUND TO BE NOT ANASTOMOSED SUCCESSFULLY AND THE STAPLES WERE NOT FORMED TO BE U-SHAPE. MANUAL SUTURING WAS PERFORMED TO RECOVER THE STAPLE LINE, AND ON THE ENTRY HOLE WITHOUT USING DEVICE.

  Patient problems: Failure to Anastomose; No Code Available

  MAUDE report 9335201 ↗
• InjuryNov 18, 2019Misfire; Failure to Form Staple; Detachment of Device or Device Component; Fail-Safe Problem; Misfire; Failure to Form Staple; Detachment of Device or Device Component; Fail-Safe Problem

  ACCORDING TO THE REPORTER, DURING HEMICOLECTOMY WITH TOTAL ABDOMINAL HYSTERECTOMY AND SALPINGO OOPHORECTOMY, AFTER OPENING THE STERILE PACKAGING, YELLOW SHIPPING WEDGE WAS ALREADY REMOVED WITHOUT EVEN REMOVING IT MANUALLY. WHEN APPLIED ON THE ANASTOMOSIS, THE FIRING KNOB BROKE FOR THE WHITE FLAG INTERLOCK ALREADY ENGAGED. IT WAS ALSO REPORTED THAT DEVICE PARTIALLY FIRED AND HAD POOR STAPLE FORMATION WHICH STAPLES GOT DISMANTLED. MISFIRED STAPLES FELL INTO THE PATIENT CAVITY. SURGEON OVERSEWED TO FIX THE STAPLE LINE.

  Patient problems: No Code Available

  MAUDE report 9335023 ↗
• MalfunctionOct 11, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER DURING A SUBTOTAL GASTRECTOMY, AT THE 1ST FIRING THE HANDLE WAS LOCKED AND WAS UNABLE TO FIRE. THE CARTRIDGE WAS REPLACED WITH A NEW ONE AND USED, BUT THE SITUATION WAS NOT IMPROVED. JUST IN CASE THE HANDLE WAS REPLACED TOGETHER, THE NEXT CARTRIDGE WAS USED WITHOUT PROBLEMS. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9182257 ↗
• MalfunctionSep 18, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, AT THE FIRST FIRING DURING ABDOMINOPERINEAL PROCTECTOMY, THE SURGEON COULD NOT FIRE THE DEVICE, AND THE KNIFE DID NOT RETURN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9084977 ↗
• MalfunctionJul 11, 2019Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING COLECTOMY FUNCTIONAL END TO END ANASTOMOSIS, AT THE FIRST FIRING, IT STOPPED HALFWAY AND WOULD NOT ADVANCE ANY FURTHER. NEW PRODUCT WAS USED AND THERE WAS NO PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8781613 ↗
• MalfunctionMar 13, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A SUB TOTAL GASTRECTOMY PROCEDURE, WHEN FIRING THE SECOND RELOAD, THE KNIFE ADVANCED ABOUT 3 CM, THEN IT DID NOT ADVANCE FURTHER AND RETURNED. WHEN A NEW PRODUCT WAS USED, STAPLING WAS ABLE TO BE PERFORMED WITHOUT PROBLEMS. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THERE WAS NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8417139 ↗
• MalfunctionJan 10, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE DID NOT FIRE. ANOTHER STAPLER USED TO COMPLETE THE CAES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8236658 ↗
• MalfunctionNov 7, 2018Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING COLECTOMY FUNCTIONAL END TO END ANASTOMOSIS, THE DEVICE WAS TAKEN OUT AND WHEN SETTING THE CARTRIDGE TO THE STAPLER FOR THE FIRST FIRING, ALTHOUGH IT COULD BE LOADED COMPLETELY, THE STAPLER COULD NOT BE CLOSED. THE PHYSICIAN MADE THE STAPLER CLOSED AND FIRED SUCCESSFULLY, HOWEVER THE CAUSE OF THE ISSUE WAS UNKNOWN. AFTER THE 2ND CARTRIDGE WAS LOADED, THE HANDLE WAS COMBINED WITH THE UPPER AND LOWER PART NORMALLY. THE DEVICE WAS NOT USED IN PATIENT. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8047017 ↗
• MalfunctionAug 10, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE FIRING KNOBS BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7772823 ↗
• MalfunctionJul 23, 2018Failure to Fire

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC COLECTOMY, THEY CONNECTED THE DEVICE TO THE RELOAD, THEN THE SURGEON TRIED TO FIRE THE DEVICE, HOWEVER COULD NOT. REPLACED BY NEW RELOAD, AND CONNECTED TO THE SAME INSTRUMENT, HOWEVER THE SAME EVENT OCCURRED. REPLACED BY ANOTHER NEW RELOAD WITH A DIFFERENT LOT NO. AND CONNECTED TO THE SAME INSTRUMENT, AND THE FIRING WAS SUCCESSFUL. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7710337 ↗