Saeed G22553Recalls & reported problems

Summary

The FDA's MAUDE database contains 289 adverse event reports that list this exact device (DI 00827002225534), received between Mar 15, 2016 and Sep 2, 2026 — classified as 35 injuries, 254 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (74 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 289 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50565485 ↗
• MalfunctionAug 31, 2026Device Handling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50530968 ↗
• InjuryAug 26, 2026Device Dislodged or Dislocated

  During a gastroscopy to ligate oesophageal varices, the physician used a Cook 6 Shooter Saeed Multi-Band Ligator. It was initially reported that the device was defective. There was no reportable information at the time.Additional information received on 29Jul2026 indicated that the clear barrel became loose from the tip of the endoscope as it was inserted in a patient oesophagus. The endoscopist did wipe the scope clean before applying the bander. The Endoscopist then retracted the scope from the patient, however the clear barrel would not pass though the patient¿s upper oesophageal sphincter, the Endoscopist tightened the string to see if it would come back out on its own but it would not come out. The Endoscopist then reinserted the scope to see where the barrel was and noticed the barrel had become completely disconnected from the string.The barrel was retrieved via a Roth net. The patient experienced trauma from trying to remove the clear barrel; some bleeding and abrasions "not serious" per the endoscopist. The bands remained in the patient as intended. According to the initial reporter, the patient did not experience any further adverse effects due to this occurrence.

  Patient problems: Foreign Body In Patient; Gastrointestinal Hemorrhage

  MAUDE report 50457772 ↗
• MalfunctionAug 11, 2026Premature Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50215045 ↗
• MalfunctionJun 11, 2026Failure to Fire; Unintended Movement

  IN PREPARATION FOR A PROCEDURE, THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE TRIGGER CORD WAS TWISTED, RENDERING IT IMPOSSIBLE TO PROCEED WITH THE PROCEDURE [UNABLE TO EFFECTIVELY DEPLOY 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 25466166 ↗
• InjuryMay 15, 2026Failure to Fire

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) IN THE LOWER ESOPHAGEAL SPHINCTER, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE PATIENT COMING FOR FIBROSCOPY, DISCOVERY OF ESOPHAGEAL VARICOSE VEIN AND LIGATION OF IT WAS NECESSARY. THE VARICOSE VEIN LIGATION DEVICE WITH ASSEMBLY WAS USED IN ACCORDANCE WITH THE CORRECT RECOMMENDATION. WHEN THE ELASTIC IS DEPLOYED, IT DID NOT LET GO AND GOT STUCK ON THE WIRE. THEREFORE, BY PULLING ON ONE OF THE VARICOSE VEINS, IT CAUSED A DIGESTIVE HEMORRHAGE THAT FORCED A STOP TO THE PROCEDURE URGENTLY FOR INTUBATION OF THE PATIENT. ONCE THE PATIENT WAS INTUBATED, THE PROCEDURE RESUMED WITH A NEW KIT, AND IT WORKED. OTHER THAN THE DEPLOYED BANDS, A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT¿S BODY. THE PATIENT WAS INTUBATED DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED DIGESTIVE BLEEDING DUE TO THIS EVENT.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 25187406 ↗
• MalfunctionMay 4, 2026Premature Activation

  DURING PREPARATION FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH VARICEAL BANDING, THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THREE BANDS OF THE LIGATOR DEPLOYED. THE END USER WAS ABLE TO USE ANOTHER OF THE SAME TO DO 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 25070717 ↗
• MalfunctionApr 28, 2026Device Dislodged or Dislocated

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE BANDS SLIPPED OFF THE VARICES. ANOTHER OF THE SAME DEVICE WAS USED 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 25021624 ↗
• MalfunctionApr 27, 2026Premature Activation

  DURING PREPARATION FOR AN ESOPHOGEAL LIGATION PROCEDURE, THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT DURING THE SETUP OF THE DEVICE THE TECH SAW SMALL PIECE OF PLASTIC INSIDE BARREL AND THOUGHT IT WAS A DEFECT. UPON INSPECTION OF THE DEVICE, THERE WAS NO DEFECT FOUND IN THE BARREL. IT APPEARS THAT DURING THE SETUP OF THE DEVICE, THE FIRST BAND WAS DEPLOYED ACCIDENTALLY AND THE PLASTIC PIECE THAT THE TECH OBSERVED INSIDE THE BARREL WAS THE SMALL PLASTIC BEAD ATTACHED TO THE TRIGGER CORD THAT DEPLOYED THE FIRST BAND. TECH OPENED ANOTHER OF THE SAME DEVICE AND PERFORMED THE PROCEDURE SUCCESSFULLY. THE OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE PATIENT SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000716 ↗
• MalfunctionMar 18, 2026Failure to Fire

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH ESOPHAGEAL BANDING, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE BANDS FAILED TO FIRE AND THE WIRE [TRIGGER CORD] TWISTED. 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 24627934 ↗
• MalfunctionFeb 25, 2026Failure to Fire

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN WANTED TO PLACE AND RELEASE THE FIRST LIGATION BAND, AFTER HE PLACED THE BAND ON THE VARICE THE TRIGGER CORD STACKED IN THE BAND AND HE COULDN´T RELEASE THE TRIGGER CORD FROM THE BAND, HE DECIDED TO PLACE SECOND BAND, BECAUSE HE THOUGHT IT WILL HELP TO RELEASE THE FIRST BAND, BUT IT DIDN´T HELP [UNABLE TO EFFECTIVELY DEPLOY BANDS-SUBJECT OF REPORT]. HE DECIDED TO STOP THE PROCEDURE. HE DIDN´T WANT TO CAUSE ANY HARM TO NOR PATIENT OR THE GASTROSCOPE, SO HE LEFT THE TRIGGER CORD WITH RESTING 4 BANDS DEPLOYED IN AND ON THE GASTROSCOPE, AND HE DECIDED TO SEND IT ALL TO GASTROSCOPE PRODUCER TO CHECK IT FOR ANY DAMAGE. ALL OTHER RESTING PARTS OF THE MBL-6 WERE THROWN AWAY. PHYSICIAN FINISHED THE PROCEDURE WITH NEW MBL-6. 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 24445887 ↗
• MalfunctionFeb 19, 2026Premature Activation

  DURING PREPARATION FOR AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT DURING THE SETUP, WHEN OPENING THE PACKAGE, ONE OF THE BANDS WAS DETACHED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE PATIENT SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388450 ↗
• MalfunctionJan 8, 2026Failure to Fire

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE FIRST SHOT [BAND DEPLOYMENT] WAS SUCCESSFUL BUT WHEN THE PHYSICIAN WANTED TO SHOOT [DEPLOY] THE SECOND SHOT [BAND], HE FELT SOMETHING WRONG. IT STUCK AND COULDN'T TURN [HANDLE]. UNDER WITHOUT SUCTION, THE SECOND SHOT [BAND] WAS SHOOT [DEPLOYED], BUT HE FOUND THE COTTON THREAD AND BEND [BAND] CONNECTED. THE PHYSICIAN DEPLOYED THE REMAINING BANDS TO TAKE THE SCOPE OUT. 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 24003097 ↗
• MalfunctionJan 6, 2026Premature Activation

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE BANDS PREMATURELY DEPLOYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN INDIGENOUS 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 23976126 ↗
• MalfunctionDec 18, 2025Use of Device Problem; Use of Device Problem

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE STRING GOT TANGLED SUCH WHERE THE BANDS ALL DEPLOYED ON THE OLYMPUS 190 EGD SCOPE. THIS OCCURRED BEFORE THE SCOPE HAD MADE CONTACT WITH THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE PATIENT SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23837112 ↗
• MalfunctionDec 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT AFTER THE DEVICE REACHED THE TARGET SITE, IT SUCCESSFULLY SUCTIONED THE TARGET POLYP, BUT EACH DEPLOYED LIGATION LOOP SLIPPED AND FAILED TO CAPTURE THE POLYP. AFTER ALL LOOPS HAD BEEN DEPLOYED WITHOUT SUCCESS, THE PHYSICIAN WITHDREW THE DEVICE, REPLACED IT WITH A NEW SET, AND SUCCESSFULLY COMPLETED THE LIGATION. 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 23717646 ↗
• MalfunctionNov 18, 2025Failure to Fire; Failure to Fire

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT DURING THE RELEASE OF THE BAND IN "FIRING" MODE, THE HANDLE DIDN'T WORK AND THE BAND WASN'T DEPLOYED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583991 ↗
• MalfunctionNov 18, 2025Product Quality Problem; Material Twisted/Bent; Product Quality Problem; Material Twisted/Bent

  DURING SET UP FOR AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE ¿KNOTTED TRIGGER CORD¿ WAS NOTICED PRIOR TO ASSEMBLY SO THERE WAS NO PATIENT OR SCOPE CONTACT. THEY INADVERTENTLY FIRED OFF SEVERAL OF THE BANDS AS THEY ATTEMPTED TO UNDO THE KNOTTED CORD. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE PATIENT SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583944 ↗
• MalfunctionNov 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE ELASTIC BANDS WOULD FALL IMMEDIATELY EVEN AFTER CORRECTING PLACING THEM [BAND FALLS OFF SITE PREMATURELY: 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532176 ↗
• MalfunctionNov 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE ELASTIC BANDS WOULD FALL IMMEDIATELY EVEN AFTER CORRECTING PLACING THEM [BAND FALLS OFF SITE PREMATURELY - 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532161 ↗
• MalfunctionNov 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE ELASTIC BANDS WOULD FALL IMMEDIATELY EVEN AFTER CORRECTING PLACING THEM [BAND FALLS OFF SITE PREMATURELY - 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532094 ↗
• MalfunctionNov 11, 2025Premature Activation; Premature Activation

  DURING PREPARATION FOR AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE TRIGGER CORD WAS BROKEN WHILE NURSE WAS LOADING THE BARREL TO THE TIP OF THE ENDOSCOPE. THEY OPENED ANOTHER BOX OF MBL-6 TO FINISH 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 23526744 ↗
• MalfunctionNov 11, 2025Premature Activation; Premature Activation

  DURING AN ENDOSCOPIC VARICEAL LIGATION PROCEDURE IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED WHEN THE DOCTOR DEPLOYED THE BAND, THE WHOLE THREAD CAME LOOSE. 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 23526708 ↗
• MalfunctionSep 2, 2025Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IN PREPARATION FOR AN UNKNOWN ENDOSCOPIC PROCEDURE IN THE STOMACH, THE PHYSICIAN SELECTED A 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT DURING INSTALLATION, THE WIRE [TRIGGER CORD] WAS BEING TENSIONED WHILE WINDING, BUT THE BLUE HOOK BROKE AND THE DEVICE BECAME UNUSABLE. A PHOTO WAS PROVIDED OF THE LOADING CATHETER WITH MISSING BLUE HOOKS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE PATIENT SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22938129 ↗
• MalfunctionAug 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING AN ENDOSCOPY WITH LIGATION OF ESOPHAGEAL VARICES, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT NO ABNORMALITIES OR DAMAGE OF THE DEVICE WERE OBSERVED WHEN IT WAS INSERTED THROUGH THE ENDOSCOPE. ONCE INSIDE THE ESOPHAGUS, THE THREADS HOLDING THE DRUM WITH THE LIGATURES INSIDE THE PATIENT BROKE. AFTER THAT, A NEW LIGATOR IS REQUESTED TO COMPLETE THE PROCEDURE. THE DAMAGED MATERIAL WAS REMOVED FROM THE PATIENT'S BODY WITH FOREIGN BODY EXTRACTION FORCEPS. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22838150 ↗