Saeed G31919Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00827002319196), received between Jun 21, 2017 and Jun 15, 2026 — classified as 1 injury, 27 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (22 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Failure to Fire

  DURING AN ENDOSCOPIC LIGATION PROCEDURE, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE PHYSICIAN USED A FUJI GASTROSCOPE TO INSTALL A LIGATION DEVICE AND ENTERED THE ESOPHAGUS. AFTER TWO BANDS OF LIGATION, THE THIRD BAND COULD NOT BE RELEASED. AFTER REMOVING THE ENDOSCOPE AND REINSTALLING THE DEVICE, IT STILL COULD NOT BE RELEASED. THE ENDOSCOPE BODY HAD BEEN TWISTED AND DEFORMED BY THE TRIGGER CORD OF THE LIGATION DEVICE. FINALLY, THE LIGATION DEVICE WAS REMOVED FROM THE GASTROSCOPE AND THE TRIGGER CORD ON THE LIGATION DEVICE WAS PULLED, AND THE BANDS FELL OFF COMPLETELY OUTSIDE THE BODY. AFTER REPLACING WITH ANOTHER BOX OF THE SAME DEVICE, THE REMAINING VARICOSE VEIN LIGATION TREATMENT WAS COMPLETED. 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 25512597 ↗
• MalfunctionJun 12, 2026Failure to Fire

  DURING AN ENDOSCOPIC LIGATION PROCEDURE FOR INTERNAL HEMORRHOIDS, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE PHYSICIAN INSTALLED THE DEVICE ONTO A FUJI ENDOSCOPE THEN ADVANCED INTO ESOPHAGUS, AFTER 3 BAND DEPLOYMENTS, THE PHYSICIAN FOUND THAT THE FOURTH BAND CANNOT BE RELEASED. USER RETRACTED THE ENDOSCOPE AND RE-INSTALLED THE DEVICE BUT STILL CANNOT RELEASE THE BAND, AND THE ENDOSCOPE BODY WAS TWISTED DUE TO TRIGGER CORD PULLING. USER CHANGED TO ANOTHER ONE OF THE SAME DEVICE TO LIGATE THE REST ESOPHAGEAL VARICES. AN UNINTENDED 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 25491018 ↗
• MalfunctionFeb 6, 2026Failure to Fire

  DURING AN ENDOSCOPIC LIGATION PROCEDURE FOR INTERNAL HEMORRHOIDS, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT WITH INTERNAL HEMORRHOIDS WAS SCHEDULED TO UNDERGO ENDOSCOPIC LIGATION OF INTERNAL HEMORRHOIDS IN THE ENDOSCOPY ROOM. DURING THE PROCEDURE, THE COOK LIGATION DEVICE ENCOUNTERED DIFFICULTIES IN RELEASE AND THE ENDOSCOPE BECAME DISTORTED. THE FIRST TWO BANDS WERE RELEASED SMOOTHLY, BUT THE THIRD BAND BEGAN TO MALFUNCTION (DIFFICULTY IN RELEASE - SUBJECT OF REPORT). AFTER REPLACING THE LIGATION DEVICE AND ENDOSCOPE, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS ADVERSE EVENT DID NOT CAUSE ANY ADVERSE REACTIONS TO THE PATIENT. 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 24277574 ↗
• MalfunctionJan 5, 2026Failure to Fire; Unintended Movement

  DURING AN ENDOSCOPIC LIGATION PROCEDURE FOR INTERNAL HEMORRHOIDS, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE USER FLIPPED THE ENDOSCOPE AND RELEASED ONE BAND AND PREPARING TO RELEASE SECOND BAND, THE BAND COULD NOT BE RELEASED. AFTER CHANGING THE ENDOSCOPE POSITION FROM REVERSE TO FORWARDING, IT STILL COULD NOT BE RELEASED. USER RETRACTED THE DEVICE FROM PATIENT BUT IT STILL COULD NOT BE RELEASED. AFTER REINSTALLING IT AGAIN, THE REMAINING BANDS COULD NOT BE RELEASED [UNABLE TO DEPLOY BANDS - SUBJECT OF REPORT]. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 23963891 ↗
• MalfunctionDec 30, 2025Failure to Fire; Failure to Fire

  DURING AN ENDOSCOPIC VARICEAL LIGATION PROCEDURE IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT AFTER 3 BANDS OF LIGATION, THE FOURTH BAND COULD NOT BE RELEASED. EVEN AFTER REMOVING THE ENDOSCOPE AND REINSTALLING IT, IT STILL COULD NOT BE RELEASED [UNABLE TO DEPLOY BANDS - SUBJECT OF REPORT]. THE ENDOSCOPE BODY HAD BEEN TWISTED AND STRETCHED BY THE TRIGGER CORD. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 23924122 ↗
• MalfunctionOct 16, 2025Failure to Fire; Failure to Fire

  DURING AN ENDOSCOPIC BAND LIGATION PROCEDURE FOR INTERNAL HEMORRHOIDS, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE RELEASED A BAND, WHICH BECAME STUCK, CAUSING THE ENDOSCOPE TO BEND. THE LIGATION DEVICE WAS REMOVED, AND THE BAND WAS PUSHED FORWARD AS A WHOLE. IT THEN RELEASED NORMALLY. HOWEVER, IT BECAME STUCK AGAIN. THE DEVICE WAS RETRACTED AND THEN CHANGED TO A NEW COOK LIGATOR DEVICE TO COMPLETE THE PROCEDURE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23316188 ↗
• MalfunctionAug 15, 2025Failure to Fire; Failure to Fire

  DURING A VARICEAL LIGATION (EVL) PROCEDURE FOR ESOPHAGEAL VARICES, THE PHYSICIAN CHOSE A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT DURING THE LIGATION PROCEDURE THE FIRST 3 BANDS RELEASED NORMALLY, BUT THE FOURTH BAND COULD NOT BE RELEASED AND WAS STUCK. USER CHANGED TO A NEW ONE [SAEED MULTI-BAND LIGATOR] TO 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 22817317 ↗
• InjuryAug 4, 2025Premature Activation; Premature Activation

  DURING AN ENDOSCOPIC VARICOSE VEIN LIGATION, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT MULTIPLE BANDS WERE DEPLOYED UNINTENTIONALLY. BALLOON PRESSURE HEMOSTASIS WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PHYSICIAN WAS UNABLE TO PLACE A BAND, AND PRESSURE HEMOSTASIS WAS PERFORMED USING A BALLOON. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 22705328 ↗
• MalfunctionAug 1, 2025Failure to Fire; Failure to Fire

  DURING AN ENDOSCOPIC ESOPHAGEAL LIGATION, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE BANDS COULD NOT BE DEPLOYED. USER RETRACTED THE ENDOSCOPE FROM PATIENT AND DISASSEMBLED THE DEVICE AND PUT IT BACK INTO PACKAGE, THEN CHANGED TO A NEW COOK LIGATOR DEVICE TO COMPLETE THE PROCEDURE. 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 22689438 ↗
• MalfunctionFeb 18, 2025Premature Activation; Premature Activation

  DURING AN ENDOSCOPIC VARICEAL LIGATION, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT TWO BANDS WERE FIRED AT THE SAME SITE AT SAME TIME. 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 21399359 ↗
• MalfunctionFeb 3, 2025Failure to Fire; Device Dislodged or Dislocated; Material Too Soft/Flexible; Failure to Fire; Device Dislodged or Dislocated; Material Too Soft/Flexible

  DURING AN ENDOSCOPIC VARICEAL LIGATION, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE BAND DID NOT TIGHTEN WELL AND THE USER WAS UNABLE TO LIGATE PROPERLY. AFTER ATTACHING THE BARREL TO THE TIP OF THE ENDOSCOPE, HE PUT IT IN HOT WATER TO WARM IT UP AND MANAGED TO USE IT. 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 21294617 ↗
• MalfunctionFeb 3, 2025Failure to Fire; Device Dislodged or Dislocated; Material Too Soft/Flexible; Failure to Fire; Device Dislodged or Dislocated; Material Too Soft/Flexible

  DURING AN ENDOSCOPIC VARICEAL LIGATION IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE PHYSICIAN OPENED THE DEVICE TO USE IT BUT THE BAND DID NOT TIGHTEN WELL AND HE WAS UNABLE TO LIGATE PROPERLY. 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 21293976 ↗
• MalfunctionJan 16, 2025Failure to Fire; Failure to Fire

  DURING AN ENDOSCOPIC HEMORRHOID LIGATION PROCEDURE IN THE RECTUM, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR [MBL]. IT WAS REPORTED [THAT] USER SUCCESSFULLY DEPLOYED FIVE BANDS, BUT SIXTH BAND CANNOT BE DEPLOYED. USER CHANGED THE ENDOSCOPE POSITION FROM RETROFLEXED TO FORWARD-VIEWING POSITION, BUT THE SIXTH BAND STILL CANNOT BE DEPLOYED. USER RETRACTED THE MBL DEVICE AND INSTALLED AGAIN AND STILL CANNOT DEPLOY THE SIXTH BAND. USER CHANGED TO A NEW MBL DEVICE TO COMPLETE THE PROCEDURE. 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 21168416 ↗
• MalfunctionAug 22, 2024Failure to Fire; Failure to Fire

  DURING AND ESOPHAGEAL VARICES LIGATION, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE USER OPENED THE PACKAGE AND INSTALLED THE DEVICE CORRECTLY AND SUCCESSFULLY DEPLOYED THE FIRST AND SECOND BANDS, BUT THIRD BAND COULD NOT BE DEPLOYED BY ROTATING THE HANDLE, AND THE ENDOSCOPE BODY TWISTED. THE USER REMOVED THE DEVICE AND INSTALLED A NEW ONE TO COMPLETE THE PROCEDURE. 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 20035411 ↗
• MalfunctionAug 15, 2024Failure to Fire; Failure to Fire

  DURING AN INTERNAL HEMORRHOID LIGATION, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE USER RELEASED 3 BANDS OF MBL-U-10 WITH ENDOSCOPE RETROFLEXED, BUT FOUND OUT THE FOURTH BAND COULD NOT BE RELEASED. THE USER ADJUSTED THE ENDOSCOPE FROM RETROFLEXED TO STRAIGHT BUT STILL COULD NOT RELEASE FOURTH BAND. THE USER THEN RETRACTED THE DEVICE AND INSTALLED THE DEVICE AGAIN BUT STILL COULD NOT RELEASE THE REMAINING BANDS. USER CHANGED TO ANOTHER NEW BML DEVICE TO 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 19990212 ↗
• MalfunctionJun 18, 2024Failure to Fire; Failure to Fire

  DURING AN INTERNAL HEMORRHOIDAL LIGATION, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE USER SUCCESSFULLY RELEASED THE FIRST 5 BANDS BUT THE SIXTH BAND COULD NOT BE RELEASED AS EXPECTED AND THE ENDOSCOPE APPEARED TWISTED. USER CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. AN UNINTENDED 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 19558276 ↗
• MalfunctionMay 10, 2024Break; Failure to Fire; Break; Failure to Fire

  DURING AN ESOPHAGEAL VARICEAL LIGATION, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE USER INSTALLED THE MBL-U-10 DEVICE ONTO OLYMPUS GIFH260 ENDOSCOPE, THEN ADVANCED THE ENDOSCOPE TO PATIENT'S ESOPHAGEAL FOR LIGATION. THE USER SUCCESSFULLY RELEASED THE FIRST 5 BANDS BUT THE SIXTH BAND COULD NOT BE DEPLOYED. USER CHANGED TO ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. 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 19288925 ↗
• MalfunctionMay 9, 2024Failure to Fire; Failure to Fire

  DURING AN INTERNAL HEMORRHOID LIGATION, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE USER DETECTED THE TRIGGER CORD ENTANGLED AND STUCK DURING THE PROCEDURE WHICH CAUSED THE BANDS TO NOT BE DEPLOYED. USER RE-INSTALLED THE DEVICE AND COMPLETED THE PROCEDURE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19278572 ↗
• MalfunctionJan 25, 2024Off-Label Use; Off-Label Use

  DURING A GASTRIC FUNDAL VARICEAL LIGATION [ABNORMAL USE], THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE USER SUCCESSFULLY RELEASED 3 BANDS BUT THE FOURTH BAND WOULD NOT DEPLOY. THE USER THEN FORCEFULLY PULLED THE TRIGGER CORD AND THE REST OF THE BANDS RELEASED TOGETHER, AND THE TRIGGER CORD RELEASED FROM THE BARREL. USER THEN CHANGED TO A DOMESTIC BRAND OF SIMILAR DEVICE TO 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 18581914 ↗
• MalfunctionNov 17, 2023Failure to Fire; Failure to Fire

  DURING AN INTERNAL HEMORRHOIDAL LIGATION, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT 3 BANDS WAS SUCCESSFULLY DEPLOYED, BUT THE DEVICE TWISTED AFTERWARD AND THE TRIGGER CORD WAS STUCK. THE USER CONTACT THE ENGINEER TO INSTALLED THE DEVICE AGAIN AND CONTINUE THE PROCEDURE. ALTHOUGH THE USER STATED THAT THE ISSUE PROLONGED THE PROCEDURE TIME AND INCREASED THE PROCEDURE RISK, THEY ALSO REPORTED THAT AN UNINTENDED 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 THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18158748 ↗
• MalfunctionFeb 24, 2023Failure to Fire; Malposition of Device; Failure to Fire; Malposition of Device

  IN PREPARATION FOR AN ENDOSCOPIC PROCEDURE FOR VARICEAL LIGATION OF ESOPHAGEAL VARICES, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE HANDLE WAS REVERSED. THIS MALFUNCTION WILL ULTIMATELY LEAD TO DIFFICULTY OR INABILITY TO EFFECTIVELY DEPLOYING BANDS, WHICH IS A REPORTABLE EVENT. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16436274 ↗
• MalfunctionJun 30, 2022Failure to Fire; Failure to Fire

  DURING A LIGATION ALONG THE MUCOSA ON HEMORRHOIDS, THE PHYSICIAN USED A 10 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE USER SUCCESSFULLY RELEASED FIRST AND SECOND BAND, BUT THE THIRD BAND COULD NOT BE RELEASED WHILE ROTATING THE HANDLE . USER THEN CHANGED TO TWO-WAY POSITION AND DISSEMBLED THE BARREL, AND MANUALLY PULLED THE TRIGGER CORD, BUT THE THIRD BAND STILL COULD NOT BE RELEASED. THE USER THEN CHANGED TO ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. 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 14876293 ↗
• MalfunctionJul 16, 2021Failure to Fire; Failure to Fire

  DURING AN ENDOSCOPIC ESOPHAGEAL VARICEAL LIGATION (EVL), THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. THE PHYSICIAN INSTALLED THE MBL-U-10 ONTO THE ENDOSCOPE (OLYMPUS GIF H260) AND ADVANCED THE DEVICE TO PATIENT'S ESOPHAGEAL CONDUCTING LIGATION. THE PHYSICIAN COMPLETED THE FIRST 3 BANDS WITH NO ISSUE, BUT THE FOURTH BAND COULD NOT BE RELEASED, THE PHYSICIAN RETRACTED THE DEVICE AND THE ENDOSCOPE FROM PATIENT AND PUT IT BACK INTO THE BOX. THE PHYSICIAN THEN CHANGED TO ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. 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 12180787 ↗
• MalfunctionFeb 25, 2021Failure to Fire; Failure to Fire

  DURING AN ENDOSCOPIC HEMORRHOIDAL LIGATION (EHL), THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. THE PHYSICIAN RELEASED THE FIRST TWO (2) BANDS SUCCESSFULLY. THE THIRD BAND COULD NOT BE RELEASED. OTHER THAN 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11378952 ↗
• MalfunctionDec 29, 2020Failure to Fire; Failure to Fire

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A 10 SHOOTER SAEED MULTI-BAND LIGATOR. THE PHYSICIAN SUCCESSFULLY RELEASED THE FIRST AND SECOND BAND. BUT, THE PHYSICIAN COULD NOT RELEASE THE THIRD BAND. THE PHYSICIAN PLACED THE HANDLE IN THE TWO-WAY POSITION, AND PULLED THE THREAD BY HAND, BUT IT STILL FAILED. THE PHYSICIAN THEN CHANGED TO ANOTHER ONE OF THE SAME DEVICES TO COMPLETE THE PROCEDURE. 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 11091394 ↗