Saeed G25119Recalls & reported problems
Cook Incorporated · Six Shooter Saeed Multi-Band Ligator · Class 2
All models of Saeed (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002251199), received between May 4, 2018 and May 29, 2026 — classified as 1 injury, 3 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.
Reports received per month
Most reported problems
Device problems
- Failure to Fire2
- Premature Activation2
- Migration or Expulsion of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2026Failure to Fire
DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN USED TWO (2) COOK 6 SHOOTER SAEED MULTI-BAND LIGATORS. IT WAS REPORTED THAT THE PROBLEM OCCURRED WHILE RELEASING THE ELASTIC BAND. WHEN ROTATING THE HANDLE, THE ELASTIC BAND DID NOT RESPOND TO THE COMMAND AND THEREFORE DID NOT ADVANCE INTO POSITION. 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 25334515 ↗MalfunctionFeb 9, 2026Premature Activation
DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE BAND FELL OFF. [PREMATURE DEPLOYMENT - SUBJECT OF REPORT]. AT THE TIME OF THIS REPORT, OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME HAVE BEEN 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. ADDITIONAL ATTEMPTS TO GATHER THIS INFORMATION WILL BE MADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24298158 ↗InjuryNov 6, 2023Failure to Fire; Failure to Fire
DURING A LIGATION PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE STRING [TRIGGER CORD] WAS CAUGHT IN A BAND. THEY WERE ABLE TO RELEASE ALL THE BANDS AND THE STRING STAYED IN THE PATIENT. AFTER REMOVING THE SCOPE THE USER CUT SOME OF THE STRING [TRIGGER CORD] THAT WAS THEN OUT OF THE PATIENT MOUTH, HELD ONTO THE STRING WITH FORCEPS AND BROUGHT IT INTO THE SCOPE, THEN CAREFULLY PLACED THE STRING INTO THE PATIENT DUODENUM.
Patient problems: Foreign Body In Patient
MAUDE report 18076012 ↗MalfunctionMay 4, 2018Migration or Expulsion of Device; Premature Activation; Migration or Expulsion of Device; Premature Activation
DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE PLASTIC END CAP [BARREL] DID NOT HOLD PROPERLY ON THE ENDOSCOPE. THE BANDS ON THE LIGATOR WERE LOOSE, UNABLE TO FIRE. ADDITIONAL INFORMATION PROVIDED BY CUSTOMER ON 4/10/2018: WE LOADED IT [THE MBL-6-XL] ONTO THE ENDOSCOPE AND ALMOST IMMEDIATELY ONE (1) BAND FELL OFF. WE ATTEMPTED TO USE THE SIX (6) SHOOTER AND TRIED TO DEPLOY THE OTHER FIVE (5) BANDS WHILE THE ENDOSCOPE WAS IN USE AND THE BANDS DID NOT REMAIN IN PLACE AND FELL OFF (SUBJECT OF THIS REPORT). WE CHECKED THE EXPIRATION DATE BECAUSE PREVIOUSLY THIS HAPPENED (SEE RELATED MDR 103905-2018-00182) WITH AN EXPIRED SIX (6) SHOOTER, BUT IT WAS NOT EXPIRED. ADDITIONAL INFORMATION PROVIDED BY CUSTOMER IN RESPONSE TO ADDITIONAL CLARIFICATION QUESTIONS ON 04/17/2018: WE WERE DOING AN EGD (GASTROSCOPY). THE BARREL WAS TIGHT AND UNMOVING ON THE ENDOSCOPE AND THE BANDS DID NOT FEEL LOOSE. BEFORE WE EVEN HAD THE CHANCE TO RE-INSERT THE ENDOSCOPE [IN] TO THE PATIENT, WE SAW ONE BAND HAD FALLEN OFF THE BARREL ONTO THE BED [PREMATURE BAND DEPLOYMENT]. THE DOCTOR INSERTED THE ENDOSCOPE INTO THE PATIENT AND DEPLOYED THE REMAINING
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7488761 ↗
Other Ligator, esophageal devices
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- Saeed G22692Cook Incorporated · Ligator, esophageal295 reports
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- Saeed G22553Cook Incorporated · Ligator, esophageal289 reports
- Saeed G31917Cook Incorporated · Ligator, esophageal123 reports
- SINGLE USE LIGATING DEVICE HX-400U-30Olympus Medical Systems Corp. · Ligator, Esophageal97 reports
- Single Use Rotatable Clip Fixing Device HX-201UR-135Olympus Medical Systems Corp. · Ligator, esophageal1 recall1 death10 reports
- Single Use Rotatable Clip Fixing Device HX-201UR-135LOlympus Medical Systems Corp. · Ligator, esophageal1 recall8 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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