Reliamax GIA6048RLRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20884521168623), received between Jul 10, 2017 and Jul 5, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionOct 8, 2019Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ESOPHAGECTOMY, THE DEVICE PARTIALLY FIRED. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9167921 ↗
• MalfunctionJun 19, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY PROCEDURE, WHEN THE SURGEON WAS ABOUT TO FIRE THE DEVICE, IT WAS BLOCKED AND COULD NOT PROCEDURE WITH THE FIRING. SURGEON COULD NOT PUSH THE FIRING KNOB. THEY TOOK ANOTHER RELOAD TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS EXTENDED BY A COUPLE OF MINUTES DUE TO RELOADING. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8711949 ↗
• MalfunctionDec 6, 2017Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN ESOPHAGECTOMY/GASTRIC TUBE PROCEDURE, FOR THE FIRST FIRING FOR CONSTRUCTION OF GASTRIC TUBE, THEY CONNECTED THE LOAD UNIT TO THE INSTRUMENT. THE SURGEON CLAMPED THE TISSUE OF STOMACH AND TRIED TO PUSH THE FIRING KNOB, HOWEVER IT WAS LOCKED AND COULD NOT PUSH IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7088281 ↗
• MalfunctionJul 10, 2017Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER: OCCURRED DURING AN OPEN PARTIAL GASTRECTOMY. DURING THE DUODENAL STUMP AND STOMACH RESECTIONING, THE STAPLES DID NOT DEPLOY FROM THE LOADING UNITS. THERE WAS SURGICAL INTERVENTION REQUIRED BECAUSE THE TISSUE HAD TO BE HAND SUTURED. THERE WAS NO EXTENSION IN SURGICAL TIME.

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

  MAUDE report 6697742 ↗