Saeed G31915Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002319158), received between Nov 17, 2017 and Jul 7, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2025Off-Label Use; Off-Label Use

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WITH STOMACH VARICES BANDING, THE PHYSICIAN USED A COOK 4 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO FIRE THE BAND AND NO BANDS WOULD DEPLOY. THE LIGATOR WAS REMOVED AND THE PROCEDURE COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO FURTHER COMPLICATIONS. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 22422202 ↗
• MalfunctionNov 14, 2019Premature Separation; Premature Separation

  DURING AN ENDOSCOPIC VARICEAL LIGATION PROCEDURE, THE PHYSICIAN USED A COOK 4 SHOOTER SAEED MULTI-BAND LIGATOR. CUSTOMER SAID THE DEVICE (4 SHOOTER) DEPLOYED THREE (3) BANDS UNINTENTIONALLY/INADVERTENTLY WITHOUT THE USER ATTEMPTING TO FIRE THEM. 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 9324388 ↗
• MalfunctionMay 3, 2019Failure to Fire; Failure to Fire

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN USED TWO (2) COOK 4 SHOOTER SAEED MULTI-BAND LIGATORS (MBL-U-4). THE MEDICAL ASSISTANT (MA) REPORTED THAT TWO (2) PIECES OF A MBL-U-4 HAD PROBLEMS IN DEPLOYING THE BANDS. SOME OF THE BANDS APPEAR TO BE STUCK ON THE BARREL AND WERE NOT ABLE TO BE DEPLOYED [UNABLE TO EFFECTIVELY DEPLOY BANDS]. ANOTHER MBL-U-4 WAS DEPLOYED AND THE CASE WAS SUCCESSFUL. 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 8579138 ↗
• MalfunctionNov 17, 2017Positioning Failure; Positioning Failure

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN USED A COOK 4 SHOOTER SAEED MULTI-BAND LIGATOR. THERE WAS NO RESISTANCE WHEN TRYING TO SHOOT OFF THE RUBBER RINGS [DIFFICULTY DEPLOYING BANDS], TUBE OF THE PRODUCT CORKSCREWED. ADDITIONAL INFORMATION RECEIVED ON 10/27/2017: WHEN STARTING TO DEPLOY THE SECOND BAND, SOME RESISTANCE WAS FELT AT THE HANDLE. THE BAND COULD NOT BE DEPLOYED [UNABLE TO DEPLOY BAND]. THE ENDOSCOPE ITSELF GOT TWISTED LIKE A CORK-SCREW [ENDOSCOPE TORQUEING]. THE ENDOSCOPE WITH THE DEVICE WAS TAKEN OUT AND A NEW MBL-U-4 WAS MOUNTED ON THE ENDOSCOPE. THE PROCEDURE WAS SUCCESSFULLY FINISHED WITH THIS DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7042716 ↗