Saeed G22613Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002226135), received between May 12, 2017 and Nov 22, 2024 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2024Premature Activation; Premature Activation

  DURING A VARICES LIGATION, THE PHYSICIAN USED A COOK 4 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT DURING THE PROCEDURE THE USER FOUND TWO MORE VARICES TO BE LIGATED SO THEY INTRODUCED THE ENDOSCOPE WITH BARREL ON. TWO (2) BANDS WERE DEPLOYED WITHOUT EVEN TURNING THE HANDLE WHICH WASN'T IN THE FIRING POSITION. THEY THEN MANAGED TO LIGATE WITH THE LAST TWO 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 20762311 ↗
• MalfunctionNov 22, 2024Premature Activation; Premature Activation

  DURING A VARICES LIGATION, THE PHYSICIAN USED A COOK 4 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT DURING THE PROCEDURE THE USER FOUND TWO MORE VARICES TO BE LIGATED SO THEY INTRODUCED THE ENDOSCOPE WITH BARREL ON. FOUR (4) BANDS WERE DEPLOYED WITHOUT EVEN TURNING THE HANDLE WHICH WASN'T IN THE FIRING POSITION. THEY THEN MANAGED TO LIGATE WITH ANOTHER OF THE SAME DEVICE. 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 20758819 ↗
• MalfunctionApr 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING AN ESOPHAGEAL VARICEAL LIGATION, THE PHYSICIAN USED A COOK 4 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE [BARREL] FELL-OFF AND INTO THE PATIENT BEFORE THE DEVICE COULD BE USED. THE BARREL WAS RETRIEVED FROM THE PATIENT'S STOMACH. ATTEMPTS HAVE BEEN MADE TO GET CLARIFICATION REGARDING HOW THE BARREL WAS RETRIEVED, HOWEVER, IT WAS REPORTED THAT THERE WERE NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16725964 ↗
• MalfunctionMay 12, 2022Failure to Fire; Failure to Fire

  DURING A GASTROSCOPY WITH ESOPHAGEAL VARICES BANDING, THE PHYSICIAN USED A COOK 4 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT WHEN THE NURSE INSTALLED THE MBL-4 ONTO THE ENDOSCOPE, THE PHYSICIAN TRIED TO SHOOT [DEPLOY] THE BAND, BUT HE FOUND THE BAND WOULD NOT DEPLOY, SO HE CHANGED TO ANOTHER OF THE SAME DEVICE TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14372572 ↗
• MalfunctionMar 20, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING AN ESOPHAGOGASTRODUODENOSCOPY FOR ENDOSCOPIC VARICEAL LIGATION, THE PHYSICIAN USED A COOK 4 SHOOTER SAEED MULTI-BAND LIGATOR. DURING ENDOSCOPIC PROCEDURE THE TIP FELL OFF OF THE PRODUCT. FOUR (4) BANDS WERE PLACED ON ESOPHAGEAL VARICES. WHEN INTUBATING THE ESOPHAGUS, THERE WAS RESISTANCE MET, BUT BANDER AND SCOPE PASSED. UPON REMOVAL OF GASTROSCOPE THE BANDER CAP SLIPPED OFF THE GASTROSCOPE AND FELL INTO THE STOMACH. PRIOR TO INTUBATION, THE PHYSICIAN SAID THE BANDER [BARREL] FELT LOOSE ON THE GASTROSCOPE. THE PHYSICIAN PROCEEDED TO COMPLETE THE CASE AND THEN THE BANDER [BARREL] FELL OFF AND INTO THE STOMACH. A RETRIEVAL NET WAS USED IN ATTEMPT TO REMOVE THE CAP [BARREL] AND WAS UNSUCCESSFUL IN MULTIPLE ATTEMPTS. THE CAP [BARREL] WAS LEFT IN THE PATIENT¿S STOMACH TO PASS. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO OTHER PROCEDURES WERE PERFORMED AFTER THE BANDS WERE DEPLOYED ON VARICES. THE BARREL OF THE LIGATOR REMAINED INSIDE THE PATIENT¿S BODY TO PASS NATURALLY. 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 9861088 ↗
• MalfunctionJul 13, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN USED A COOK 4 SHOOTER SAEED MULTI-BAND LIGATOR. THE BANDS SLIPPED OFF AFTER BANDING [BAND SLIPS OFF SITE PREMATURELY]. THE DOCTOR TRIED TO DEPLOY THE SECOND, THIRD, AND EVEN THE LAST BAND. ALL [THE BANDS] SLIPPED OFF. THE STAFF NURSE (SN) CONFIRMED THAT THE SUCTION WAS WORKING AS USUAL. ADDITIONAL INFORMATION WAS RECEIVED ON 28-JUNE-2018: THE BANDS SLIPPED OFF THE VARIX. 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 7685363 ↗
• MalfunctionSep 1, 2017Premature Activation; Premature Activation

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK SHOOTER SAEED MULTI-BAND LIGATOR. ONE OF THE RINGS [BANDS] OF THE MBL-4 WAS LYING LOOSE IN THE PACKAGE [PREMATURE DEPLOYMENT OF BANDS].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6837384 ↗
• MalfunctionJun 8, 2017Premature Activation; Premature Activation

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK 4 SHOOTER SAEED MULTI-BAND LIGATOR. WHEN THE NURSE INSTALLED THE DEVICE, SHE FOUND THE STRING OF THE CAP IS IN THE WRONG POSITION. THE NURSE TOLD THE PHYSICIAN AND IT WAS CHANGED TO ANOTHER DEVICE. THEN, THE SECOND DEVICE WAS OKAY.ON (B)(6)2017, THE DEVICE WAS EVALUATED VIA SIMULATED TESTING. IT WAS FOUND THAT THE BANDS DEPLOYED PREMATURELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6627834 ↗
• MalfunctionMay 12, 2017Positioning Failure; Positioning Failure

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN USED A COOK 4 SAEED SHOOTER MULTI-BAND LIGATOR. TWO (2) OUT OF THE FOUR (4) ELASTIC BANDS WERE BLOCKED DURING THE RELEASING ON THE ESOPHAGEAL VARICES [UNABLE TO EFFECTIVELY DEPLOY BANDS]. THE CUSTOMER NEEDED TO USE ANOTHER DEVICE TO DEPLOY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6562800 ↗