Saeed G22692Recalls & reported problems

Summary

The FDA's MAUDE database contains 295 adverse event reports that list this exact device (DI 00827002226920), received between Feb 26, 2016 and Sep 25, 2026 — classified as 8 injuries, 287 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (142 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 295 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Premature Activation

  During preparation for an endoscopic variceal ligation in the esophagus, the physician selected a Cook 6 Shooter Saeed Multi-Band Ligator.It was reported that the user opened the package and discovered that the bands had premature released. The user changed to another device to complete the procedure.This occurred prior to patient contact; there was no impact to the patient. In addition, the patient sustained no clinical consequence and there were no adverse effects to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898341 ↗
• MalfunctionSep 25, 2026Premature Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898053 ↗
• MalfunctionSep 25, 2026Failure to Fire

  During an endoscopic variceal ligation in the esophagus, the physician used a Cook 6 Shooter Saeed Multi-Band Ligator. It was reported that after assembling the ligature, the ligator is moved to the target area for ligation treatment. The ligator could not be released normally by the fourth band, The endoscope was then removed and replaced with a new device to complete the procedure.Other than the 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 50897830 ↗
• MalfunctionSep 24, 2026Premature Activation

  Patient problems: Foreign Body In Patient

  MAUDE report 50891193 ↗
• MalfunctionSep 24, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882776 ↗
• MalfunctionSep 24, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882698 ↗
• MalfunctionSep 16, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791464 ↗
• MalfunctionSep 14, 2026Premature Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763328 ↗
• MalfunctionSep 14, 2026Premature Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763004 ↗
• MalfunctionSep 14, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50762646 ↗
• MalfunctionAug 25, 2026Failure to Fire

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 50436708 ↗
• MalfunctionAug 24, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50412866 ↗
• MalfunctionAug 12, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50226222 ↗
• MalfunctionJun 26, 2026Premature Activation

  DURING AN ENDOSCOPIC VARICEAL LIGATION IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT WHEN THE THIRD BAND WAS RELEASED AND THE FOURTH BAND WAS READY TO BE RELEASED, IT COULD NOT BE ROTATED FOR RELEASE. EVEN AFTER ADJUSTING THE POSITION, IT COULD NOT BE RELEASED. USER HAD TO RETRACT THE ENDOSCOPE, REPLACE THE LIGATION DEVICE WITH A NEW ONE, AND CONTINUE THE TREATMENT. AN UNINTENDED 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 25641615 ↗
• MalfunctionJun 17, 2026Failure to Fire

  DURING AN ENDOSCOPIC VARICEAL LIGATION IN THE ESOPHAGUS, THE PHYSICIAN USED TWO (2) COOK 6 SHOOTER SAEED MULTI-BAND LIGATORS. IT WAS REPORTED THAT THE BAND ENTANGLED WITH TRIGGER CORD, BANDS CANNOT BE DEPLOYED. 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 25536489 ↗
• MalfunctionJun 10, 2026Failure to Fire

  DURING AN ENDOSCOPIC VARICEAL LIGATION IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE PHYSICIAN INSTALLED THE DEVICE NORMALLY, AFTER ASPIRATION THE PHYSICIAN RELEASED THE DEVICE AND FOUND THAT THE RELEASED WHITE BAND STUCK UNDER BAND AND THE ENDOSCOPE CANNOT BE RETRACTED. AFTER RELEASING ALL THE RUBBER RINGS [BANDS] AT ONCE, THE ENDOSCOPE CAN BE RETRACTED. OTHER THAN THE DEPLOYED BANDS WHICH WILL PASS NATURALLY, 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 25459625 ↗
• MalfunctionJun 5, 2026Failure to Fire

  DURING AN ENDOSCOPIC VARICEAL LIGATION IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT AFTER TWO BANDS OF LIGATION, THE THIRD BAND COULD NOT BE RELEASED. AFTER REMOVING THE ENDOSCOPE AND REINSTALLING THE DEVICE, IT STILL COULD NOT BE RELEASED. THE ENDOSCOPE BODY HAD BEEN SEVERELY TWISTED BY THE TRIGGER CORD OF THE DEVICE. AFTER REPLACING WITH ANOTHER BOX OF MBL-6-F, THE REMAINING VARICOSE VEIN LIGATION WAS COMPLETED. 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 25406609 ↗
• MalfunctionJun 4, 2026Premature Activation

  DURING AN ENDOSCOPIC VARICEAL LIGATION IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT DURING INSTALLATION THE BANDS DETACHED. USER CHANGED TO A NEW DEVICE TO COMPLETE THE PROCEDURE. 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 25397388 ↗
• MalfunctionJun 4, 2026Premature Activation

  DURING AN ENDOSCOPIC VARICEAL LIGATION IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT DURING INSTALLATION THE BANDS DETACHED. USER CHANGED TO A NEW DEVICE TO COMPLETE THE PROCEDURE. 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 25394821 ↗
• MalfunctionMay 12, 2026Premature Activation

  DURING AN ESOPHOGEAL LIGATION PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE PATIENT HAS A HISTORY OF HEPATITIS B-RELATED CIRRHOSIS ACCOMPANIED BY ESOPHAGOGASTRIC VARICES. HE PRESENTED WITH "HEMATEMESIS" AND WAS ADMITTED TO THE OPERATING ROOM FOR "ESOPHAGEAL VARICEAL LIGATION + GASTRIC VARICEAL TISSUE GLUE CLOSURE" UNDER GENERAL ANESTHESIA WITH TRACHEAL INTUBATION FROM 23:20 ON (B)(6) 2026, TO 23:39 ON THE SAME DAY. DURING THE ESOPHAGEAL VARICEAL LIGATION PROCEDURE, AN ADVERSE EVENT OCCURRED WHEN SIX BANDS WERE RELEASED SIMULTANEOUSLY [BANDS PREMATURELY DEPLOY - SUBJECT OF REPORT] DURING THE LIGATION OF THE BLOOD VESSELS AT THE CARDIA. THEREFORE, THE SECOND LIGATION DEVICE WAS PROMPTLY REPLACED, AND THE BLOOD VESSELS WERE LIGATED IN A CIRCULAR MANNER FROM THE BOTTOM UP. AFTER THE PROCEDURE, THE VARICES IN THE UPPER ESOPHAGUS WERE SIGNIFICANTLY REDUCED. THE PATIENT'S VITAL SIGNS WERE STABLE, AND HE WAS ESCORTED BACK TO THE WARD AFTER RESUSCITATION. THIS EVENT OCCURRED DURING THE PROCEDURE, WITH SIX BANDS RELEASED SIMULTANEOUSLY AROUND THE BLOOD VESSELS, RESULTING IN SIGNIFICANT EDEMA AROUND THE VESSELS BUT NO VESSEL RUPTURE OR MAJOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149106 ↗
• MalfunctionApr 27, 2026Premature Activation

  DURING PREPARATION FOR AN ESOPHOGEAL LIGATION PROCEDURE, THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE USER OPENED THE PACKAGE AND DISCOVERED THAT THE BANDS DETACHED [PREMATURE DEPLOYMENT-SUBJECT OF REPORT]. A NEW LIGATION DEVICE WAS SUBSTITUTED TO COMPLETE THE PROCEDURE THE OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE PATIENT SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000041 ↗
• MalfunctionApr 21, 2026Premature Activation

  DURING AN ENDOSCOPIC VARICEAL LIGATION FOR CIRRHOTIC ESOPHAGOGASTRIC VARICES, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT FOUR BANDS WERE RELEASED AT ONE TIME. THE DEVICE FUNCTIONED NORMALLY AFTER REPLACEMENT WITH A NEW LIGATOR. AN UNINTENDED 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 24939105 ↗
• MalfunctionMar 4, 2026Off-Label Use

  DURING AN ENDOSCOPIC PROCEDURE IN THE STOMACH, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT UPON RELEASING THE FIRST RUBBER BAND FROM THE LIGATURE, HE LOOSENED THE CORD AND RELEASED ALL THE RUBBER BANDS [PREMATURE DEPLOYMENT] 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 24505526 ↗
• MalfunctionMar 4, 2026Failure to Fire

  DURING AN ENDOSCOPIC LIGATION PROCEDURE FOR INTERNAL HEMORRHOIDS IN THE ANORECTAL REGION, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE PATIENT WAS ALREADY IN POSITION, AND THE NURSE INSTALLED DEVICE NORMALLY. HOWEVER, THE FIRST ATTEMPT TO RELEASE [BANDS] WAS UNSUCCESSFUL AS THE PATIENT'S POSITION WAS ADJUSTED THE ANGLE. WHEN ATTEMPTING TO RELEASE IT AGAIN, THE DEVICE GOT STUCK. THE NURSE QUICKLY REPLACED IT WITH A NEW SET OF LIGATING DEVICES AND COMPLETED THE PROCEDURE. 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 24505273 ↗
• MalfunctionMar 2, 2026Failure to Fire

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE USER ATTACHED THE COOK BAND LIGATION DEVICE MBL-6-F TO THE ENDOSCOPE AND PROCEEDED WITH THE BAND LIGATION TREATMENT THROUGH THE PATIENT'S MOUTH INTO THE ESOPHAGUS. WHEN STARTING WITH THE FIRST BAND, USER FELT THAT THE TENSION OF THE TRIGGER CORD WAS STRONG MAKING IT DIFFICULT TO TRIGGER THE BAND TO RELEASE. WHEN RELEASING THE SECOND BAND, USER DESCRIBED THAT EVEN THOUGH SHE PULLED HARD ON THE TRIGGER CORD, SHE COULDN'T TRIGGER THE BAND TO RELEASE. IT MIGHT BE THAT THE THIRD BAND RELEASED UNEXPECTEDLY UNDER FORCE, FAILING TO BAND THE TARGET AREA, AND DUE TO THE TIGHTNESS OF THE TRIGGER CORD, IT WAS DIFFICULT TO TRIGGER. THEREFORE, THE DEVICE HAD TO BE REMOVED AND REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. 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 24485121 ↗