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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

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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 ↗

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Sources and updates

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