Reliamax GIA6038RLRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 20884521168616), received between Nov 13, 2017 and Aug 18, 2021 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2021Component or Accessory Incompatibility; Protective Measures Problem; Component or Accessory Incompatibility; Protective Measures Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN HEMICOLECTOMY PROCEDURE, BEFORE LOADING THE RELOAD, IT WAS FOUND OUT THAT THE BLADE WAS ALREADY OUT. THERE WAS DIFFICULTY IN LOADING AND THE USER COULD NOT JOIN THE TWO HALVES OF THE STAPLER. A NEW RELOAD 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 12338693 ↗
• MalfunctionMar 10, 2021Break; Expulsion; Break; Expulsion

  ACCORDING TO THE REPORTER, DURING AN OPEN ESOPHAGECTOMY, ON FIRST RELOAD, THE BLUE PART AND WHITE ATTACHING END OF THE RELOAD WAS BROKEN. WHILE ON THE SECOND RELOAD, STAPLES PIN WAS ALREADY OUT AND COULD NOT FIRE. ON THIRD RELOAD, THE WHITE SAFETY LOCK WAS OUT, AND IT COULD NOT FIRE THE STAPLER. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11458148 ↗
• MalfunctionJul 2, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE DISTRIBUTOR FACILITY, 4 SHIPPING WEDGES WERE MOVED FROM POSITION AND THE BLADE GUARD WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10226701 ↗
• MalfunctionNov 14, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, AT THE END OF THE FIRST FIRING DURING SIGMOIDECTOMY, THE STAPLES WERE NOT STAPLED WELL. A REINFORCEMENT WAS PERFORMED WITH A NEW PRODUCT TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9325246 ↗
• MalfunctionJul 23, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE FIRST FIRING DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY, WHEN THE RELOAD WAS ATTACHED, THE KNOB BROKE AND CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE EVENT OCCURRED DURING THE PROCEDURE, BUT THE PRODUCT WAS NOT USED FOR PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8815598 ↗
• MalfunctionJun 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, FIRING KNOB OF 3 DEVICE CARTRIDGE DISENGAGED AFTER OPENING THE STERILE PACK AND 4 CARTRIDGES THE WHITE SHIELD AUTOMATICALLY COVERED THE BLADE AFTER OPENING THE STERILE PACK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8662900 ↗
• MalfunctionFeb 6, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A GASTRECTOMY, WHILE THE DOCTOR TRIED TO LOAD THE CARTRIDGE ON THE STAPLER THE BLADE PART WAS BROKEN DUE TO WHICH IT COULDN'T BE LOADED. ANOTHER CARTRIDGE WAS USED TO COMPLETE THE CASE. THE EVENT OCCURRED DURING PROCEDURE BUT THE DEVICE WAS NOT USED IN THE PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8313024 ↗
• MalfunctionNov 12, 2018Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING THE FUNCTIONAL END TO END RECONSTRUCTION OF TRANSVERSE COLON IN A COLECTOMY PROCEDURE, WHEN THE SURGEON TRIED TO PERFORM THE 2ND FIRING, THE FIRING STOPPED MIDWAY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE TISSUE WAS NOT STIFF OR THICK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8059758 ↗
• MalfunctionOct 23, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING ESOPHAGECTOMY, THE DEVICE WAS APPLIED AT THE ANASTOMOSIS NEAR NECK TO RESECT THE STUMP HOWEVER IT DID NOT FIRE. THE BLACK KNOB WAS ABLE TO MOVE ONLY TILL HALF AND THEN THE KNOB WAS STUCK IN BETWEEN. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7994856 ↗
• InjurySep 24, 2018Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN TRIPLE BYPASS AND SPECIMEN WAS TAKEN FROM THE PANCREATIC HEAD, THERE WAS A POOR STAPLE FORMATION AND BLEEDING FROM THE STAPLE LINE. THE STAPLE LINE WAS FIXED THRU OVER SEWING IN ORDER TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

  Patient problems: No Code Available

  MAUDE report 7901844 ↗
• MalfunctionJul 6, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHILE USING THE SECOND CARTRIDGE DURING THE OPEN TOTAL GASTRECTOMY, THE DEVICE DID NOT FIRE. THE SURGEON COULD NOT PUSH THE FIRING KNOB AND GOT STUCK. THE SURGEON OPENED AND USED ANOTHER CARTRIDGE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7666589 ↗
• MalfunctionFeb 21, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FIRING PIECE OF THE LOADING UNIT BROKE AND DISENGAGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7287445 ↗
• MalfunctionNov 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER: THERE ARE NON-HEMOSTATIC ISSUES WITH BLEEDING EDGES WITH THE STAPLER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7025021 ↗