Saeed G24748Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002247482), received between Aug 26, 2016 and May 26, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (2 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.

• MalfunctionMay 26, 2023Device Dislodged or Dislocated; Material Too Soft/Flexible; Device Dislodged or Dislocated; Material Too Soft/Flexible

  DURING AN ESOPHAGEAL VARICEAL LIGATION, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT WHEN THE BANDS ARE RELEASED, SOME GRAB AND OTHERS DO NOT HOLD THE VARICE, LEAVING IT LOOSE. OTHER THAN THE DEPLOYED BANDS, A SECTION OF THE DEVICE DID NOT REMAIN IN 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 17013141 ↗
• MalfunctionMay 8, 2023Premature Activation; Premature Activation

  DURING A GASTROENDOSCOPY, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT TWO BANDS WERE RELEASED AT ONCE. COULD NOT CONTINUE BINDING WITH THAT DEVICE. 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 16890368 ↗
• MalfunctionOct 6, 2022Failure to Fire; Unintended Movement; Failure to Fire; Unintended Movement

  DURING PREPARATION FOR AN ESOPHAGEAL VARICES LIGATION, THE PHYSICIAN PREPARED TO USE A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT WHEN THE PHYSICIAN OPENED THE PACKAGE, HE REALIZED THAT THE LIGATOR CORD LOOKED STRANGE, SO HE DIDN'T USE IT. IMAGES PROVIDED SHOW THAT THE TRIGGER CORD IS NOT PROPERLY RETAINED UNDER THE BANDS CAUSING BANDS TO NOT DEPLOY OR DIFFICULTY TO DEPLOY. AS IT WAS DISCOVERED PRIOR TO PATIENT CONTACT, 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 AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15551125 ↗
• MalfunctionMar 24, 2021Failure to Fire; Failure to Fire

  DURING A ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN USED 6 SHOOTER SAEED MULTI-BAND LIGATOR. WHEN THE VARICOSE WAS SUCTIONED, THE LIGATION WAS NOT RELEASED [UNABLE TO DEPLOY]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENTS 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 11563307 ↗
• MalfunctionOct 4, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IN THE TWO (2) BARRELS, SEVERAL LIGATURES [BANDS] WERE RELEASED WITH THE CORRECT PROTOCOL. THESE SACKED FROM THE VARICEAL PACKAGE [UNABLE TO EFFECTIVELY DEPLOY BANDS], AND THEY WERE IN ESOPHAGUS. A VIDEO PROVIDED SHOWS ONE OF THE TWO BARRELS PROVIDED BEING USED. TWO (2) BANDS DEPLOYED SUCCESSFULLY. THE THIRD AND FOURTH BANDS WERE UNABLE TO BE EFFECTIVELY DEPLOYED. THE DEVICE WAS REMOVED, AND THE THIRD AND FOURTH BANDS REMOVED FROM THE INSIDE THE BARREL. THE USER THEN REINTRODUCED THE DEVICE AND SUCCESSFULLY DEPLOYED THE FIFTH BAND. THE SIXTH BAND WAS UNABLE TO BE EFFECTIVELY DEPLOYED AND THE DEVICE WAS REMOVED. THE ADDITIONAL INFORMATION INDICATES THAT OF THE 12 TOTAL BANDS, 6 ON EACH BARREL, 7 BANDS WERE SUCCESSFULLY DEPLOYED. OTHER THAN THE SUCCESSFULLY DEPLOYED BANDS, 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 9158697 ↗
• MalfunctionAug 26, 2016Difficult To Position; Premature Activation; Difficult To Position; Premature Activation

  DURING AN ESOPHAGEAL VARICEAL LIGATION, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE FOLLOWING WAS REPORTED TO CUSTOMER RELATIONS: "THE LIGATOR WAS PLACED IN THE GASTROSCOPY; WHEN THE DRUM [LIGATOR] WAS INTRODUCED TO THE SITE OF LIGATION THE BANDS RELEASED INTO THE LARYNX AND ESOPHAGUS WITHOUT BEING DRIVEN [THE BANDS PREMATURE DEPLOYED]. THESE LOOSE BANDS WERE EXTRACTED WITH SUCTION. IT CHANGES A NEW DRUM [A NEW LIGATOR WAS USED]."

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 5906639 ↗