Saeed G31918Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002319189), received between Jan 19, 2021 and Apr 22, 2026 — classified as 1 injury, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Device Handling Problem

  IN PREPARATION FOR A GASTROSCOPY PROCEDURE FOR A BLEEDING ESOPHAGEAL VARIX, THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT PRIOR TO USE THE PHYSICIAN ALWAYS FIRES OFF ONE BAND, AND IT DOES NOT FIRE CORRECTLY, IT'S NOT ROUND AND ALMOST FOLDED OVER. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUES. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE USER SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955075 ↗
• MalfunctionApr 6, 2026Device Handling Problem

  IN PREPARATION FOR AN UNKNOWN VARICEAL LIGATION PROCEDURE, THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT PRIOR TO USE THE PHYSICIAN ALWAYS FIRES OFF ONE BAND, THE BANDS STAYED OPEN AND DID NOT CONSTRICT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUES. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE USER SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24788855 ↗
• InjuryJan 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A VARICEAL LIGATION, THE PHYSICIAN USED TWO COOK 6 SHOOTER SAEED MULTI-BAND LIGATORS. IT WAS INITIALLY REPORTED THAT 2 BANDERS THAT WERE DEFECTIVE. THE NURSE, TECH AND PROVIDER ALL WITNESSED THE BANDER PROPERLY SEAT ON A VARIX AND SUBSEQUENTLY ROLL OFF OF THE VARIX. A THIRD KIT WAS USED TO COMPLETE THE PROCEDURE. WE RECEIVED ADDITIONAL INFORMATION ON 19JAN2024, STATING THAT THIS CASE WAS FOR UPPER GI BLEED WITH ESOPHAGEAL VARICES. THERE WAS NO PREVIOUS SCARING OR DIFFICULTY REACHING THE SITE THAT WAS TO BE BANDED. THIS WAS A STANDARD BANDING WITH NO TORQUE IN THE SCOPE. IT WAS SUPPOSED TO BE A STRAIGHTFORWARD BANDING CASE. BANDS WERE PLACED IN THE ESOPHAGUS AND THE TEAM WATCHED THE BAND ROLL UP THE VARIX AND POP OFF. A SECOND BANDER WAS USED IN AN ATTEMPT TO TRY AGAIN. THE BANDER WAS IN GOOD POSITION, BUT AGAIN THE BAND ROLLED OFF OF THE VARIX. AT THIS TIME A THIRD BANDER WAS USED, BUT DUE TO THE PREVIOUS ATTEMPTS THE VIEW WAS OBSTRUCTED BY BLOOD AND THE THIRD BANDER WAS NEVER FIRED. THE PATIENT ENDED UP GOING FOR A TIPSS PROCEDURE DUE TO THE BLEEDING.

  Patient problems: Gastrointestinal Hemorrhage; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475733 ↗
• MalfunctionMar 18, 2021Failure to Fire; Failure to Fire

  DURING AN ENDOSCOPIC INTERNAL HEMORRHOID LIGATION, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE PHYSICIAN SUCCESSFULLY RELEASED THE FIRST THREE (3) BANDS BUT THE FOURTH ONE WAS STUCK, AND THE ENDOSCOPE CHANNEL APPEARED TWISTED. THE NURSE FOUND THAT THE ENDOSCOPE CHANNEL WAS BLOCKED WHILE CLEANING THE ENDOSCOPE, WHICH WILL NEED TO BE REPAIRED. THE PHYSICIAN COMPLETED THE LIGATION MANUALLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516655 ↗
• MalfunctionMar 16, 2021Failure to Fire; Failure to Fire

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THERE WAS A MALFUNCTION WHEN THE BANDS WERE RELEASED (UNABLE TO EFFECTIVELY DEPLOY BANDS). OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11495878 ↗
• MalfunctionJan 19, 2021Failure to Fire; Failure to Fire

  DURING AN INTERNAL HEMORRHOID LIGATION, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE PHYSICIAN RELEASED THE FIRST BAND SUCCESSFULLY, BUT COULD NOT RELEASE THE SECOND BAND [SUBJECT OF THIS REPORT]. THE HANDLE COULD NOT BE ADJUSTED OR SHIFTED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11195405 ↗