ReliamaxRecalls & reported problems across all models

We found 7 models of Reliamax by Covidien LP in the FDA's device registry (GUDID). Together they are named in 63 adverse event reports in the FDA's MAUDE database, received between Jul 10, 2017 and May 18, 2022 — classified as 1 death, 9 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (19 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Reliamax problems

Reliamax models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Reliamax GIA8038RL

  STAPLE, IMPLANTABLE
  1 death32 reports
• Reliamax GIA6038RL

  STAPLE, IMPLANTABLE
  13 reports
• Reliamax GIA6048RL

  STAPLE, IMPLANTABLE
  7 reports
• Reliamax GIA8048RL

  STAPLE, IMPLANTABLE
  5 reports
• Reliamax GIA60RS

  STAPLE, IMPLANTABLE
  3 reports
• Reliamax GIA80RS

  STAPLE, IMPLANTABLE
  2 reports
• Reliamax GIA6025RL

  STAPLE, IMPLANTABLE
  1 report

Recent Reliamax adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJan 5, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN GASTROINTESTINAL ANASTOMOSIS PROCEDURE, THE DEVICE DID NOT FIRE. THE BLACK PUSHER THUMB PIECE CANNOT BE MOVED AT ALL. THE LOADING UNIT 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 13168935 ↗
• 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 ↗
• MalfunctionJul 5, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN ESOPHAGECTOMY, UPON MAKING POUCH OF STOMACH, THE PUSHING KNOB OF BOTH DOWN LOADING UNIT BROKE. SURGEON WAS NOT ABLE TO DO ARTICULATION AND FOUND LOOSE END OF FAN AT JOINT PART. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12119330 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 4, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON AN OPEN ANTERIOR RESECTION, DURING RESECTION, A PART OF THE RELOAD DISENGAGED. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10365278 ↗
• MalfunctionJul 24, 2020Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN LAPAROTOMY WITH ILEOSTOMY PROCEDURE, THE DEVICE DID NOT FIRE. THE BLACK KNOB COULD NOT MOVE AHEAD AND WHEN FORCE WAS APPLIED THE BLACK KNOB BROKE OFF. THE SURGEON THEN USED ANOTHER DEVICE LOADING TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10323770 ↗
• MalfunctionJul 17, 2020Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE LOADING UNIT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10292728 ↗
• 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 ↗

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• Tri-Staple 2.037 models · 4,892 reports · 2 recalls
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