Saeed G26861Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00827002268616), received between May 31, 2016 and Mar 22, 2021 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (7 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2021Premature Activation; Premature Activation

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE BANDS FAILED TO DEPLOY. SUCTION WAS APPLIED TO THE VARICES AND THE BANDS SLIPPED FROM THE BARREL [PREMATURELY DEPLOYED] AND DID NOT HOLD THE VARICES. 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 11542369 ↗
• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE BANDS WERE DEPLOYED, BUT UNFORTUNATELY THE NEXT DAY THE PATIENT PRESENTED BLEEDING BUT HAS RECOVERED AND IS NOW STABLE. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED A SECOND LIGATION PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 11530005 ↗
• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE BANDS WERE DEPLOYED, BUT UNFORTUNATELY THE NEXT DAY THE PATIENT PRESENTED BLEEDING BUT HAS RECOVERED AND IS NOW STABLE. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED AN ADDITIONAL LIGATION PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 11529958 ↗
• MalfunctionMar 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE BAND FLIPPED [SLIPPED] FROM THE VARICES. 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. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS 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 11420837 ↗
• MalfunctionFeb 23, 2021Premature Activation; Premature Activation

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE BANDS SLIPPED [PREMATURELY DEPLOYED]. OTHER THAN THE DEPLOYED BAND(S), 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 11365700 ↗
• MalfunctionFeb 15, 2021Failure to Fire; Unintended Movement; Failure to Fire; Unintended Movement

  IN PREPARATION FOR AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE THREAD LOOP WAS OVERLAPPED ON THE BAND AND DID NOT RELEASE [UNABLE TO EFFECTIVELY DEPLOY BAND]. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11328970 ↗
• MalfunctionSep 14, 2020Device Dislodged or Dislocated; Device Handling Problem; Device Dislodged or Dislocated; Device Handling Problem

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. WHILE APPLYING THE FIRST BAND, THE THREAD WAS STUCK ALONG WITH THE BAND ON THE VARIX, AND THE GASTROSCOPE COULD NOT BE WITHDRAWN. IMMEDIATELY, THE PHYSICIAN DISLODGED ALL OTHER BANDS INSIDE [THE PATIENT], AND REMOVED THE GASTROSCOPE WITH DIFFICULTY. 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 Consequences Or Impact To Patient

  MAUDE report 10529321 ↗
• MalfunctionJul 22, 2020Premature Separation; Premature Separation

  IN PREPARATION FOR AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. WHEN THE PACKAGE WAS OPENED ONE BAND HAD ALREADY SLIPPED OFF OF THE BARREL [PREMATURE DEPLOYMENT] AND THE THREAD WAS BROKEN [TRIGGER CORD BREAKS]. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10307189 ↗
• MalfunctionFeb 27, 2020Migration; Migration

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN USED A 6 COOK SHOOTER SAEED MULTI-BAND LIGATOR. THE COMPLAINT DEVICE WAS INITIALLY REPORTED AS AN MANUFACTURING DEFECT. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ON 03-FEB-2020, CLARIFICATION WAS RECEIVED ABOUT THE MANUFACTURING DEFECT. THE BAND SLIPPED OFF THE SITE PREMATURELY. OTHER THAN THE DEPLOYED BAND, 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 9763969 ↗
• MalfunctionNov 8, 2019Premature Separation; Premature Separation

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE BARREL WAS DETACHED FROM BAND IN THE PACKET [BAND PREMATURELY DEPLOYED]. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9297811 ↗
• MalfunctionJun 22, 2018Premature Activation; Premature Activation

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE CUSTOMER OPENED THE COOK BAND [LIGATOR] AND THE RING [BAND] WAS ALREADY DISPLACED FROM ITS PLACE (PREMATURE BAND DEPLOYMENT). THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7628708 ↗
• MalfunctionJan 26, 2018Premature Activation; Premature Activation

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED TWO (2) COOK 6 SHOOTER SAEED MULTI-BAND LIGATORS (MBL-6-I-5B-S). LIGATION WAS TO BE PERFORMED ON THE ESOPHAGEAL VARICES AND THE MBL-6-1-5B-S WAS USED. AFTER PACKET OPENING, IT WAS FOUND THE LIGATOR ALREADY SLIPPED OUTSIDE THE OPTIVUE BARREL [PREMATURE BAND DEPLOYMENT]. TWO (2) PACKETS WERE OPENED AND FOUND LIKE THIS. THEY ARE RETURNING ONE (1) PACKET; ONE (1) WAS DESTROYED. ADDITIONAL INFORMATION WAS RECEIVED ON 01/04/2018: THE BAND WAS FOUND OFF OF THE BARREL [PREMATURE BAND DEPLOYMENT]. THIS OCCURRED PRIOR TO USE. AFTER THEY FOUND IT IN ONE (1) PACKET, THEY OPENED ANOTHER PACKET AND IT WAS ALSO THE SAME.

  Patient problems: No Patient Involvement

  MAUDE report 7221087 ↗
• MalfunctionDec 21, 2017Shelf Life Exceeded; Improper or Incorrect Procedure or Method; Device Operates Differently Than Expected; Shelf Life Exceeded; Improper or Incorrect Procedure or Method; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THERE WAS NO BAND RETENTION; THE BANDS DID NOT HOLD THE VARICES [BANDS SLIPS OFF SITE PREMATURELY].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7137633 ↗
• MalfunctionDec 21, 2017Shelf Life Exceeded; Improper or Incorrect Procedure or Method; Device Operates Differently Than Expected; Shelf Life Exceeded; Improper or Incorrect Procedure or Method; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN USED THREE (3) COOK 6 SHOOTER SAEED MULTI-BAND LIGATORS. THERE WAS NO BAND RETENTION; THE BANDS DID NOT HOLD THE VARICES [BANDS SLIP OFF SITE PREMATURELY].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7137630 ↗
• MalfunctionDec 1, 2017Premature Activation; Premature Activation

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED TWO (2) COOK 6 SHOOTER SAEED MULTI-BAND LIGATORS. THE BAND WAS DISLODGED PRIOR TO LOADING ONTO THE ENDOSCOPE. THE BAND WAS FOUND DISLODGED THE MOMENT THE PACK WAS OPENED [PREMATURE BAND DEPLOYMENT].

  Patient problems: No Patient Involvement

  MAUDE report 7076415 ↗
• MalfunctionApr 10, 2017Premature Activation; Premature Activation

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK 6 SHOOTER SAEED MULTIBAND LIGATOR. WHEN THE PACKET WAS OPENED, ONE (1) LATEX BAND WAS OUT SIDE THE BARREL, SO IT WAS NOT USED AND THE MANUFACTURER WAS INFORMED. THE SAME PROCEDURE WAS COMPLETED BY OUR ANOTHER SET OF LIGATOR BARRELS (THE THIRD OF WHICH PERFORMED TO THE FULLEST).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6477297 ↗
• MalfunctionDec 29, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC ESOPHAGEAL VARICEAL LIGATION (EVL) PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE RUBBER BAND HAS LOST ITS ELASTICITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6213526 ↗
• MalfunctionMay 31, 2016Premature Activation; Premature Activation

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. AS REPORTED IN THE DOCTOR LETTER: "THIS IS TO CERTIFY THAT H.MM AND MY CARE OF OGD [ESOPHAGOGASTRODUODENOSCOPY] AND EVL [ESOPHAGEAL VARICES LIGATION]. COOK BAND WHICH USED IN PROCEDURE HAD ALREADY BROKEN BEFORE USE. SO PLEASE REPLACE IT WITH REG." AS REPORTED IN DEALER LETTER: "DEAR SIR/MADAM, WE HAD SUPPLIED MBL-6-I-5B-S TO (B)(6). DURING THE PROCEDURE DR. (B)(6) FOUND FAULTY PRODUCT TWICE. ONE TIME THE BAND DIDN'T WORK PROPERLY [MDR 1037905-2016-00160] AND ANOTHER TIME ONE BAND WAS ALREADY OUTSIDE THE INSTRUMENT OPEN [MDR 1037905-2016-00161]. LOT NO [NUMBER]- W3650928 - DIDN'T WORK PROPERLY. [MDR 1037905-2016-00160]. LOT NO [NUMBER] W3639801- ONE SINGLE BAND WAS OPEN FROM THE INSTRUMENT ITSELF. [MDR 1037905-2016-00161]. I AM SENDING BOTH THE LOT NO [NUMBER] PRODUCT. KINDLY SEND US THE REPLACEMENT PRODUCT. I HAVE ATTACHED DOCTOR'S COMPLAINT LETTER. PLEASE PROCESS THIS URGENTLY."

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5689067 ↗
• MalfunctionMay 31, 2016Difficult or Delayed Positioning; Difficult or Delayed Positioning

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. AS REPORTED IN THE DOCTOR LETTER: "THIS IS TO CERTIFY THAT (B)(6). AND MY CARE OF OGD [ESOPHAGOGASTRODUODENOSCOPY] AND EVL [ESOPHAGEAL VARICES LIGATION]. COOK BAND WHICH USED IN PROCEDURE HAD ALREADY BROKEN BEFORE USE. SO PLEASE REPLACE IT WITH REG." [MDR 1037905-2016-00161]. AS REPORTED IN DEALER LETTER: "DEAR SIR/MADAM, WE HAD SUPPLIED MBL-6-I-5B-S TO (B)(6)HOSPITAL (B)(6). DURING THE PROCEDURE DR. (B)(6) FUND FAULTY PRODUCT TWICE. ONE TIME THE BAND DIDN'T WORK PROPERLY AND ANOTHER TIME ONE BAND WAS ALREADY OUTSIDE THE INSTRUMENT OPEN [MDR 1037905-2016-00161]. LOT NO [NUMBER]- W3650928 - DIDN'T WORK PROPERLY. LOT NO [NUMBER] W3639801- ONE SINGLE BAND WAS OPEN FROM THE INSTRUMENT ITSELF. [MDR 1037905-2016-00161]. I AM SENDING BOTH THE LOT NO [NUMBER] PRODUCT. KINDLY SEND US THE REPLACEMENT PRODUCT. I HAVE ATTACHED DOCTOR'S COMPLAINT LETTER. PLEASE PROCESS THIS URGENTLY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5689060 ↗