Saeed G25424Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002254244), received between Nov 14, 2019 and Apr 6, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Device Dislodged or Dislocated

  IN PREPARATION FOR AN ESOPHAGOGASTRODUODENOSCOPY WITH BANDING, THE PHYSICIAN SELECTED FOUR COOK 6 SHOOTER SAEED MULTI-BAND LIGATORS. IT WAS REPORTED THAT THE LIGATING CAP WAS FAILING TO ATTACH CORRECTLY, KEEPS SLIPPING OFF THE DISTAL END OF THE SCOPE WHEN ATTEMPTING TO FIT. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE USER SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793253 ↗
• InjuryJan 17, 2024Off-Label Use; Off-Label Use

  DURING AN ESOPHAGEAL VARICEAL LIGATION IN A PEDIATRIC DIGESTIVE FUNCTIONAL EXPLORATION SERVICE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT AFTER A FIRST SUCCESSFUL LIGATURE, THE ELASTIC USED ON A SECOND VARICE WAS SUCKED UP BY THE ENDOSCOPE. THE ISSUE OCCURRED 3 TIMES IN SPITE OF A CHANGE OF LOT NUMBER AND ENDOSCOPE OPERATOR (OTHER LOT AFFECTED - CAPTURED IN A SEPARATE REPORT). ALTHOUGH THE INSTRUCTIONS FOR USE DO NOT EXPLICITLY STATE THAT THE DEVICE CANNOT BE USED ON A PEDIATRIC PATIENT, THESE DEVICES SHOULD ONLY BE USED WITH ADULT PATIENTS AS THEY WERE NOT TESTED ON PEDIATRIC POPULATIONS NOR WERE THEY APPROVED FOR PEDIATRIC USE. THESE TRIALS EXTENDED THE PROCEDURE BY AN HOUR UNDER GENERAL AESTHESIA. PATIENT INJURED NOSE THROAT BECAUSE THE DEVICE WAS INTRODUCED THROUGH THE NOSE. IMPORTANT BLEEDING. NIGHT IN INTENSIVE CARE UNIT. PACK OF BLOOD & PLATELETS. FURTHER INFORMATION IS REQUESTED.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 18529607 ↗
• InjuryJan 17, 2024Off-Label Use; Off-Label Use

  DURING AN ESOPHAGEAL VARICEAL LIGATION IN A PEDIATRIC DIGESTIVE FUNCTIONAL EXPLORATION SERVICE, THE PHYSICIAN USED TWO COOK 6 SHOOTER SAEED MULTI-BAND LIGATORS. IT WAS REPORTED THAT AFTER A FIRST SUCCESSFUL LIGATURE, THE ELASTIC USED ON A SECOND VARICE WAS SUCKED UP BY THE ENDOSCOPE. THE ISSUE OCCURRED 3 TIMES IN SPITE OF A CHANGE OF LOT NUMBER AND ENDOSCOPE OPERATOR (OTHER LOT AFFECTED - CAPTURED IN A SEPARATE REPORT). ALTHOUGH THE INSTRUCTIONS FOR USE DO NOT EXPLICITLY STATE THAT THE DEVICE CANNOT BE USED ON A PEDIATRIC PATIENT, THESE DEVICES SHOULD ONLY BE USED WITH ADULT PATIENTS AS THEY WERE NOT TESTED ON PEDIATRIC POPULATIONS NOR WERE THEY APPROVED FOR PEDIATRIC USE. THESE TRIALS EXTENDED THE PROCEDURE BY AN HOUR UNDER GENERAL AESTHESIA. PATIENT INJURED NOSE THROAT BECAUSE THE DEVICE WAS INTRODUCED THROUGH THE NOSE. IMPORTANT BLEEDING. NIGHT IN INTENSIVE CARE UNIT. PACK OF BLOOD & PLATELETS. FURTHER INFORMATION IS REQUESTED.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 18529037 ↗
• MalfunctionApr 7, 2023Failure to Fire; Unintended Movement; Failure to Fire; Unintended Movement

  IN PREPARATION FOR A LIGATION PROCEDURE, THE PHYSICIAN PREPARED TO USE A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE THREADS WERE TWISTED AND COULD NOT BE USED [LEADS TO DIFFICULTY DEPLOY BANDS]. AS THE OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT, 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, AND 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 16701626 ↗
• MalfunctionNov 14, 2019Premature Separation; Premature Separation

  DURING AN ENDOSCOPIC VARICEAL LIGATION PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE DEVICE DEPLOYED THREE (3) BANDS WITHOUT ATTEMPTING TO DO IT . SINCE THERE WERE STILL THREE (3) BANDS ON THE 6 SHOOTER, THEY DELIBERATELY TRIED TO DEPLOY AND GOT TWO (2) GOOD DEPLOYMENTS (BANDS #4 AND #5) TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE SIXTH BAND ON THE 6 SHOOTER WAS NOT ATTEMPTED TO BE USED BECAUSE IT WAS NOT NEEDED. 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 9324392 ↗