Saeed G25221Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00827002252219), received between Feb 16, 2016 and Oct 30, 2024 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IN PREPARATION FOR A LIGATION PROCEDURE, THE PHYSICIAN SELECTED TWO COOK 6 SHOOTER SAEED MULTI-BAND LIGATORS. IT WAS REPORTED THAT THEIR COLONOSCOPES ARE 12.8 DIAMETER AND BOTH TIMES THE DEVICE WOULD NOT STAY ON THE END, IT JUST POPS RIGHT OFF, SO BOTH WERE THROWN AWAY. THIS OCCURRED PRIOR TO PATIENT CONTACT SO THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568431 ↗
• MalfunctionAug 28, 2024Material Separation; Material Separation

  IN PREPARATION FOR AN UNSPECIFIED LIGATION PROCEDURE, THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT DURING SET UP FOR THE PROCEDURE, THE BARREL WAS PLACED ON THE SCOPE. THE BARREL WAS LOOSE AND IT WAS NOTED THAT THE BARREL HAD A CRACK IN IT [BARREL DETACHED FROM FRICTION-FIT ADAPTER]. 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 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 20086546 ↗
• MalfunctionOct 25, 2022Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  DURING A COLONOSCOPY FOR HEMORRHOIDAL LIGATION, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT DURING THE SET-UP WHEN THEY WERE PULLING THE LOADING CATHETER WITH THE TRIGGER CORD THROUGH THE SCOPE, IT GOT STUCK AROUND THE BIOPSY CAP/HANDLE, THEY PULLED IT MORE AND THAT¿S WHEN THE BLUE HOOK BROKE. THEY TRY TO USE THE OTHER HOOK ON OTHER END BUT SAME THING HAPPENED. THEY END UP USING HEMOSTAT FORCEPS TO GRAB THE TRIGGER CORD AND WAS ABLE TO COMPLETE THE SET UP AND DO THE CASE. 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 15668884 ↗
• MalfunctionSep 23, 2022Failure to Fire; Failure to Fire

  DURING AN UNSPECIFIED LIGATION PROCEDURE THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT WHEN THE TECH LOADED THE BANDER ONTO THE SCOPE AND THE PHYSICIAN TURNED THE HANDLE, NO BANDS MOVED OFF THE BARREL. THEY UNLOADED THE DEVICE FROM THE SCOPE AND COMPLETED THE PROCEDURE SUCCESSFULLY WITH A NEW KIT. 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 15472903 ↗
• MalfunctionAug 9, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  DURING AN ENDOSCOPIC HEMORRHOIDAL BANDING PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. AS THEY [PHYSICIAN] WERE LOADING THE TRIGGER CORD, THE END PIECE OF THE LOADING CATHETER BROKE OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A MANUAL HEMORRHOID BANDER. 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 12293151 ↗
• MalfunctionJun 13, 2019Failure to Fire; Failure to Fire

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THEY WERE ONLY ABLE TO DEPLOY TWO (2) BANDS AND WERE NOT ABLE TO DEPLOY ANY AFTER. 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 Consequences Or Impact To Patient

  MAUDE report 8695900 ↗
• InjuryMar 11, 2019Entrapment of Device; Difficult or Delayed Separation; Entrapment of Device; Difficult or Delayed Separation

  DURING A COLONOSCOPY WITH BANDING, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. AFTER THE LAST BAND WAS DEPLOYED, THE STRING [TRIGGER CORD] FROM THE DEVICE WAS STUCK UNDER THE BAND. THEY CUT THE STRING AND REMOVED THE ENDOSCOPE. THEY WENT BACK IN WITH THE ENDOSCOPE TO CUT THE STRING AT THE BAND [IN ORDER TO REMOVE THE ENDOSCOPE]. THEY DO NOT KNOW IF ANY OF THE STRING REMAINED IN THE PATIENT. OTHER THAN THE DEPLOYED BAND, IT IS UNKNOWN IF A PORTION OF THE STRING OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY TO PASS NATURALLY. THE PATIENT REQUIRED THE STRING TO BE CUT FROM THE BAND IN ORDER TO REMOVE THE ENDOSCOPE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

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

  MAUDE report 8409068 ↗
• MalfunctionOct 12, 2018Premature Activation; Detachment of Device or Device Component; Premature Activation; Detachment of Device or Device Component

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE NOTE ON THE BOX SAYS THAT IT WILL NOT FIT ON THE TIP OF THE ENDOSCOPE. LOT # W4094748. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018: THE BANDER [BARREL] FAILED TO STAY ON THE ENDOSCOPE, IT KEPT FALLING OFF. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018: [THE BARREL KEPT FALLING OFF] AFTER BEING PLACED ON THE ENDOSCOPE BUT PRIOR TO BEING INTRODUCED INTO THE PATIENT. IT WOULD NOT FIT ON THE END OF THE ENDOSCOPE. [THE DEVICE] SHOT OFF TWO (2) OR THREE (3) BANDS [PREMATURE BAND DEPLOYMENT]. THE DEVICE WAS NOT USED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7960810 ↗
• MalfunctionJul 23, 2018Premature Activation; Premature Activation

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE ITEM, MBL-6-XL-C (G25221) LOT W4070139, WAS DEFECTIVE DURING A CASE YESTERDAY IN OUR OPERATING ROOM (OR). I WAS TOLD THAT THE BANDS KEPT FALLING OFF AND NOT STAYING ON THE CAMERA. ADDITIONAL INFORMATION WAS RECEIVED ON 10-JULY-2018: THE BANDS PREMATURELY DEPLOYED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7710525 ↗
• MalfunctionJun 5, 2018Detachment Of Device Component; Use of Device Problem; Compatibility Problem; Detachment Of Device Component; Use of Device Problem; Compatibility Problem

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE KIT (BARREL) WOULD NOT STAY ATTACHED TO THE ENDOSCOPE. THEY HAD TO OPEN A NEW KIT AND COMPLETED THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 7570438 ↗
• MalfunctionFeb 17, 2016Detachment Of Device Component; Premature Activation; Detachment Of Device Component; Premature Activation

  DURING AN ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE USER REPORTED DIFFICULTY GETTING THE BARREL ON TO THE END OF THE SCOPE AND KEEPING IT ON THE END OF THE SCOPE. IT IS SLIPPING OFF. THE BANDS ARE SLIPPING OFF OF THE BARREL BEFORE THEY CAN BE DEPLOYED.

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

  MAUDE report 5441886 ↗
• MalfunctionFeb 16, 2016Detachment Of Device Component; Premature Activation; Detachment Of Device Component; Premature Activation

  DURING AN ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE USER REPORTED DIFFICULTY GETTING THE BARREL ON TO THE END OF THE ENDOSCOPE AND KEEPING IT ON THE END OF THE ENDOSCOPE. IT IS SLIPPING OFF. THE BANDS ARE SLIPPING OFF OF THE BARREL BEFORE THEY CAN BE DEPLOYED.

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

  MAUDE report 5439352 ↗