Saeed G22614Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002226142), received between Mar 5, 2018 and Apr 21, 2025 — classified as 2 deaths, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Premature Activation; Premature Activation

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE 10 ELASTICS [BANDS] WERE RELEASED 2 AT A TIME, SO FIVE WERE RELEASED BUT 10 ELASTICS [WERE] PUT ON. 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 21875680 ↗
• MalfunctionSep 28, 2023Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  DURING AN UNSPECIFIED LIGATION PROCEDURE, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE KNOT ON THE TWINE WAS "MUCH LARGER AND AS A RESULT WHEN PULLING THE THREADS THROUGH, THE BLUE PIECE CAME OFF OF THE WHITE PLASTIC THREADER' [BLUE HOOK DETACHES]. AS A RESULT, THE PROCEDURE TIME WAS EXTENDED AND WE HAD TO ADMINISTER ADDITIONAL SEDATION TO THE PATIENT. 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 17837264 ↗
• MalfunctionFeb 17, 2022Device Dislodged or Dislocated; Material Too Soft/Flexible; Device Dislodged or Dislocated; Material Too Soft/Flexible

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. BEFORE USING THE PRODUCT, THE DOCTORS TESTED 1 BAND. AND THEY NOTICED THAT THE BAND LOST ITS ELASTICITY. THE VIDEO PROVIDED DEPICTS A TABLE TOP TEST AND THE BANDS FROM AN OPENED MBL NOT CONSTRICTING ONCE OFF THE BARREL. 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 13551024 ↗
• MalfunctionFeb 17, 2022Device Dislodged or Dislocated; Material Too Soft/Flexible; Device Dislodged or Dislocated; Material Too Soft/Flexible

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. BEFORE USING THE PRODUCT, THE DOCTORS TESTED 1 BAND. AND THEY NOTICED THAT THE BAND LOST ITS ELASTICITY. THE VIDEO PROVIDED DEPICTS A TABLE TOP TEST AND THE BANDS FROM AN OPENED MBL NOT CONSTRICTING ONCE OFF THE BARREL. 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 13550953 ↗
• MalfunctionJan 17, 2022Failure to Fire; Failure to Fire

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT "THE SHOOTER WAS BROKEN. PULLING ON THE BALL DOES NOT WORK TO GET THROUGH THE BARREL [DIFFICULT OR UNABLE TO DEPLOY - SUBJECT OF REPORT]." 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 13266105 ↗
• MalfunctionJul 21, 2020Premature Activation; Premature Activation

  IN PREPARATION FOR A ENDOSCOPIC LIGATION PROCEDURE, THE PHYSICIAN SELECTED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. THE MBL -10 SHOOTER WAS FOUND TO BE DEFECTIVE WHEN PROCEDURAL STAFF OPENED THE PACKET. THEY NOTICED THAT A COUPLE OF RUBBER LATEX BANDS WERE ALREADY LOOSE IN THE PACKET OR CAME OFF OF THE TIP [BARREL] WHEN THEY OPENED IT. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10302781 ↗
• MalfunctionJul 11, 2019Use of Device Problem; Failure to Fire; Device-Device Incompatibility; Use of Device Problem; Failure to Fire; Device-Device Incompatibility

  DURING AN ESOPHAGEAL VARICEAL LIGATION PROCEDURE, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. THE TRIGGER CORD SPLIT INTO THE OPERATOR CHANNEL OF THE ENDOSCOPE PREVENTING ROTATION OF THE HANDLE THEREFORE BLOCKING THE RELEASE OF THE ELASTICS [UNABLE TO EFFECTIVELY DEPLOY 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 8782527 ↗
• DeathMar 5, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR (MBL-10). IN THE PROCESS OF USING THE MBL-10, DURING THE OPERATION, IT WAS NOTICED THAT THE RING [BAND] SHRUNK SLOWLY. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018: AFTER LIGATION, TWO (2) PATIENTS HAD RELAPSES OF BLEEDING AND WE DID NOT FIND THE BANDS DURING REVISION (SUBJECT OF THIS REPORT AND SEE RELATED MDR 1037905-2018-00080). THEN WE PERFORMED A CONTROL GASTROSCOPY AND A BLAKEMORE SONDE [TUBE] WAS PLACED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018: CONTROL GASTROSCOPY WAS PERFORMED IN BOTH EVENTS WITH THE TWO (2) PATIENTS. THEY HAD STRONG BLEEDING AND THERE WAS NO CHOICE, THE PHYSICIAN HAD TO MAKE A CONTROL DIAGNOSTIC. FOR BOTH EVENTS, WITH PATIENTS, IT WAS CAUSED BY LOW-QUALITY BAND LIGATION SYSTEMS (BANDS FELL OFF THE SITE PREMATURELY AND CAUSED A RELAPSE OF BLEEDING). THERE WAS NOTHING TO DO EXCEPT FOR CONTROL GASTROENTEROLOGY AND THE BLAKEMORE TUBE PLACEMENTS, BECAUSE THE LIGATIONS DID NOT WORK PROPERLY. BOTH PATIENTS PASSED AWAY AT THAT MOMENT (ONE DURING PLACEMENT AND ANOTHER ONE RIGHT AFTER IT) (SUBJ

  Patient problems: Death

  MAUDE report 7314947 ↗
• DeathMar 5, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR (MBL-10). IN THE PROCESS OF USING THE MBL-10, DURING THE OPERATION, IT WAS NOTICED THAT THE RING [BAND] SHRUNK SLOWLY. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018: AFTER LIGATION, TWO (2) PATIENTS HAD RELAPSES OF BLEEDING AND WE DID NOT FIND THE BANDS DURING REVISION (SUBJECT OF THIS REPORT AND SEE RELATED MDR 1037905-2018-00081). THEN WE PERFORMED A CONTROL GASTROSCOPY AND A BLAKEMORE SONDE [TUBE] WAS PLACED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018: CONTROL GASTROSCOPY WAS PERFORMED IN BOTH EVENTS WITH THE TWO (2) PATIENTS. THEY HAD STRONG BLEEDING AND THERE WAS NO CHOICE, THE PHYSICIAN HAD TO MAKE A CONTROL DIAGNOSTIC. FOR BOTH EVENTS, WITH PATIENTS, IT WAS CAUSED BY LOW-QUALITY BAND LIGATION SYSTEMS (BANDS FELL OFF THE SITE PREMATURELY AND CAUSED A RELAPSE OF BLEEDING). THERE WAS NOTHING TO DO EXCEPT FOR CONTROL GASTROENTEROLOGY AND THE BLAKEMORE TUBE PLACEMENTS, BECAUSE THE LIGATIONS DID NOT WORK PROPERLY. BOTH PATIENTS PASSED AWAY AT THAT MOMENT (ONE DURING PLACEMENT AND ANOTHER ONE RIGHT AFTER IT) (SUBJ

  Patient problems: Death

  MAUDE report 7314945 ↗