Saeed G24654Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00827002246546), received between Nov 8, 2016 and Sep 10, 2026 — classified as 12 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Device Dislodged or Dislocated; Material Too Soft/Flexible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718168 ↗
• MalfunctionSep 1, 2026Premature Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50547218 ↗
• MalfunctionMay 5, 2026Premature Activation

  DURING PREPARATION FOR AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE LIGATOR MISFIRED [PREMATURELY DEPLOYED - SUBJECT OF REPORT]. THE END USER WAS ABLE TO USE ANOTHER OF THE SAME 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 25083008 ↗
• MalfunctionMay 5, 2026Premature Activation

  DURING PREPARATION FOR AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE LIGATOR MISFIRED [PREMATURELY DEPLOYED - SUBJECT OF REPORT]. THE END USER WAS ABLE TO USE ANOTHER OF THE SAME 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 25082520 ↗
• MalfunctionMar 4, 2026Use of Device Problem

  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 THERE WERE NO DIFFICULTIES ENCOUNTERED DURING THE ASSEMBLY. HOWEVER, DURING USE, THE BANDS DO NOT HOLD. THE 1ST RUBBER BAND COMES OFF WHILE THE ROPE IS NOT TAUT. DURING THE LIGATIONS, ONE OF THE FOUR (4) BANDS DID NOT HOLD UNTIL THE END OF THE PROCEDURE, THE LAST TWO (2) BANDS DEPLOYED AT THE SAME TIME. 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 24510431 ↗
• MalfunctionFeb 9, 2026Device Handling Problem

  DURING SETUP FOR AN UNKNOWN BANDING PROCEDURE, THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE BANDS MALFUNCTIONED, ALL BANDS ARE NOT TIGHT. THE DEVICE NEVER MADE CONTACT WITH PATIENT BECAUSE THE DOCTOR INSTRUCTED TECH TO ¿TEST FIRE¿ BANDS OUTSIDE OF THE PATIENT AND WASN¿T CONVINCED THE BANDS WOULD HOLD, BASED ON THEIR APPEARANCE. 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 24294657 ↗
• MalfunctionFeb 9, 2026Device Handling Problem

  DURING SETUP FOR AN UNKNOWN BANDING PROCEDURE, THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE BANDS MALFUNCTIONED, ALL BANDS ARE NOT TIGHT. THE DEVICE NEVER MADE CONTACT WITH PATIENT BECAUSE THE DOCTOR INSTRUCTED TECH TO ¿TEST FIRE¿ BANDS OUTSIDE OF THE PATIENT AND WASN¿T CONVINCED THE BANDS WOULD HOLD, BASED ON THEIR APPEARANCE. 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 24293862 ↗
• MalfunctionApr 1, 2025Premature Activation; Premature Activation

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH ESOPHAGEAL BANDING, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT UPON DEPLOYING 1 BAND, MULTIPLE BANDS DEPLOYED. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE USE OF THE DEVICE IN QUESTION. 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 21740954 ↗
• MalfunctionFeb 4, 2025Misassembly by Users; Misassembly by Users

  IN PREPARATION FOR A LIGATION PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS INITIALLY REPORTED THAT THE KNOT ON THE STRING WAS TOO BIG TO FIT THROUGH THE HANDLE ON THE SCOPE. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE RETURNED ON 09 JAN 2025 WITH A BLUE HOOK DETACHED AS WELL AS A BAND PREMATURELY DEPLOYED (BOTH REPORTED TO HAVE RESULTED FROM THE REPORTED DIFFICULTY PULLING THROUGH SCOPE). THIS OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21302486 ↗
• MalfunctionNov 12, 2024Misassembly by Users; Misassembly by Users

  DURING AN ESOPHAGEAL VARICEAL LIGATION, THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT AN END PIECE FELL OFF [BLUE HOOK DETACHED FROM LOADING CATHETER]. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20667299 ↗
• MalfunctionJul 15, 2022Premature Activation; Premature Activation

  DURING A PROCEDURE FOR BANDING OF VARICES IN THE STOMACH, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE DEVICE WAS LOADED INTO THE ENDOSCOPE CORRECTLY BUT WHEN THE PHYSICIAN SLOWLY TURNED THE HANDLE THERE WAS NO CLICK OR RESISTANCE. THE TURNING MECHANISM WAS SMOOTH AND SUDDENLY ALL 6 BANDS CLOSED IN ON THE VARIX. 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 15029823 ↗
• MalfunctionJun 1, 2022Device Dislodged or Dislocated; Material Too Soft/Flexible; Device Dislodged or Dislocated; Material Too Soft/Flexible

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE PHYSICIAN TRIED TO DEPLOY THE BAND ON THE BLEEDING VARICES BUT THE BAND SLIPPED OFF [VARICES], SO THE PHYSICIAN OPTED TO USE A COOK DUETTE KIT INSTEAD AND SUCCESSFULLY COMPLETED 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: Gastrointestinal Hemorrhage

  MAUDE report 14565940 ↗
• MalfunctionNov 11, 2021Failure to Fire; Failure to Fire

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THEY WERE BANDING A PATIENT AND THE CORD ON THE BANDER FRAYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME AS THERE WAS NO DIFFICULTY NOTED, JUST FRAYING. THE DEVICE WAS RECEIVED AND THE BANDS WERE DEPLOYED IN THE PACKAGING. DUE TO THE SUM OF THE ORIGINALLY REPORTED INFORMATION AND THE STATE THE DEVICE WAS RECEIVED IN, IT IS REASONABLE TO CONCLUDE THAT THE DEVICE WAS DIFFICULT TO USE [SUBJECT OF REPORT]. 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 12799039 ↗
• InjuryOct 7, 2021Device Dislodged or Dislocated; Device Handling Problem; Device Dislodged or Dislocated; Device Handling Problem

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE PHYSICIAN WAS USING THE MBL-6-OV AND THE BARREL SLIPPED OFF THE SCOPE AND HAD TO BE RETRIEVED OUT OF THE STOMACH WITH A NET. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE BARREL THAT FELL OFF THE END OF THE SCOPE REQUIRED THE PHYSICIAN TO RETRIEVE THE BARREL FROM THE PATIENTS STOMACH. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE AND THE PROCEDURE WAS COMPLETED WITH THE DEVICE IN QUESTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 12593192 ↗
• MalfunctionAug 18, 2021Break; Break

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT AFTER THE PROCEDURE HAD FINISHED, WHEN REMOVING THE DEVICE FROM THE SCOPE, THE WHITE STRING BROKE HALF WAY DOWN THE CHANNEL WHEN PULLING IT OUT OF THE PATIENT. "AS WE WERE RETRACTING GASTROSCOPE THE STRING SNAPPED FOR NO OBVIOUS REASON AND THE PLASTIC DISTAL CAPPED DISLODGE OFF END OF SCOPE INTO PATIENT ESOPHAGUS ENDING UP IN THE STOMACH. MULTIPLE ATTEMPTS WITH DIFFERENT PRODUCTS WERE USED TO RETRIEVE THE CAP. IN THE END WE RETRIEVED WITH A RAT TOOTH FORCEP AND NOTHING BUT THE SUCCESSFUL BANDS WERE LEFT INSIDE THE PATIENT." A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT¿S BODY HOWEVER IT WAS SUCCESSFULLY RETRIEVED WITH A RAT TOOTH FORCEP. 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: Foreign Body In Patient

  MAUDE report 12338838 ↗
• MalfunctionSep 17, 2020Misassembly by Users; Premature Separation; Misassembly by Users; Premature Separation

  PRIOR TO AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE, THE USER SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. ONE OF THE BLUE HOOKS BROKE OFF THE LOADING CATHETER AS THEY WERE TRYING TO PULL IT OUT OF THE TOP OF THE ENDOSCOPE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. ADDITIONAL INFORMATION RECEIVED ON 16-SEP-2020 NOTED THAT UPON PICKING UP THE DEVICE FROM THE CUSTOMER, IT WAS REVEALED THAT NONE OF THE BLUE HOOKS WERE BROKEN OFF. WHEN THE TECHNICIAN WAS PUTTING THE BANDER ONTO THE ENDOSCOPE, SHE ATTACHED THE LOADING CATHETER TO THE STRING. THE HOOK WAS PLACED RIGHT NEXT TO THE KNOT, WHICH IS NOT RECOMMENDED. WHEN SHE PULLED THE LOADING CATHETER OUT OF THE ENDOSCOPE WITH THE STRING NEXT TO THE KNOT, IT DEPLOYED SEVERAL BANDS [PREMATURE BAND DEPLOYMENT]. THIS INITIAL PROBLEM WAS USER ERROR. ANOTHER TECHNICIAN SET UP ANOTHER BANDER, AND IT WORKED FINE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10550067 ↗
• InjuryAug 10, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. POST PROCEDURE, THE PATIENT EXPERIENCED MAJOR HEMORRHAGES WHEN PRESSURE ULCERS FELL OFF AFTER IV LIGATION. THE PATIENT HAD TO BE HOSPITALIZED IN INTENSIVE CARE FOR AN EXTENDED STAY. ADDITIONAL INFORMATION RECEIVED ON 22-JULY-2020 STATED: THEY DIDN¿T CHANGE MEDICAL TREATMENT (ANTICOAGULATION¿) FOR PATIENT. ADDITIONAL INFORMATION RECEIVED ON 27-AUGUST-2020 STATED: THIS IS NOT A BAND SLIP OFF [BAND DID NOT SLIP OFF VARIX], AS THE EVENT OCCURRED SEVERAL DAYS AFTER DELIVERY. THE DOCTOR EXPLAINED THAT HEMORRHAGES OCCURRED WHEN THE VARIX WAS OCCLUDED AND NECROSED DUE TO THE BAND. THE NORMAL PATHWAY AT THIS STAGE IS THAT THE VARIX AND BAND FALL SPONTANEOUSLY. IN THIS CASE, WHEN THE BAND AND THE NECROSED VARIX FELL FROM THE ESOPHAGUS, THE HEALING WAS NOT DONE AND THE PATIENT BLED. OTHER THAN THE DEPLOYED BANDS, A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED MAJOR HEMORRHAGES. THE PATIENT WAS HOSPITALIZED IN INTENSIVE CARE FOR AN EXTENDED STAY.

  Patient problems: Gastrointestinal Hemorrhage; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10388302 ↗
• InjuryAug 10, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. POST PROCEDURE, THE PATIENT EXPERIENCED MAJOR HEMORRHAGES WHEN PRESSURE ULCERS FELL OFF AFTER IV LIGATION. THE PATIENT HAD TO BE HOSPITALIZED IN INTENSIVE CARE FOR AN EXTENDED STAY. ADDITIONAL INFORMATION RECEIVED ON 22-JULY-2020 STATED: THEY DIDN¿T CHANGE MEDICAL TREATMENT (ANTICOAGULATION¿) FOR PATIENT. ADDITIONAL INFORMATION RECEIVED ON 27-AUGUST-2020 STATED: THIS IS NOT A BAND SLIP OFF [BAND DID NOT SLIP OFF VARIX], AS THE EVENT OCCURRED SEVERAL DAYS AFTER DELIVERY. THE DOCTOR EXPLAINED THAT HEMORRHAGES OCCURRED WHEN THE VARIX WAS OCCLUDED AND NECROSED DUE TO THE BAND. THE NORMAL PATHWAY AT THIS STAGE IS THAT THE VARIX AND BAND FALL SPONTANEOUSLY. IN THIS CASE, WHEN THE BAND AND THE NECROSED VARIX FELL FROM THE ESOPHAGUS, THE HEALING WAS NOT DONE AND THE PATIENT BLED. OTHER THAN THE DEPLOYED BANDS, A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED MAJOR HEMORRHAGES. THE PATIENT WAS HOSPITALIZED IN INTENSIVE CARE FOR AN EXTENDED STAY.

  Patient problems: Gastrointestinal Hemorrhage; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10388126 ↗
• InjuryAug 10, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. POST PROCEDURE, THE PATIENT EXPERIENCED MAJOR HEMORRHAGES WHEN PRESSURE ULCERS FELL OFF AFTER IV LIGATION. THE PATIENT HAD TO BE HOSPITALIZED IN INTENSIVE CARE FOR AN EXTENDED STAY. ADDITIONAL INFORMATION RECEIVED ON 22-JULY-2020 STATED: THEY DID NOT CHANGE MEDICAL TREATMENT (ANTICOAGULATION¿) FOR PATIENT. ADDITIONAL INFORMATION RECEIVED ON 27-AUGUST-2020 STATED: THIS IS NOT A BAND SLIP OFF [BAND DID NOT SLIP OFF VARIX], AS THE EVENT OCCURRED SEVERAL DAYS AFTER DELIVERY. THE DOCTOR EXPLAINED THAT HEMORRHAGES OCCURRED WHEN THE VARIX WAS OCCLUDED AND NECROSED DUE TO THE BAND. THE NORMAL PATHWAY AT THIS STAGE IS THAT THE VARIX AND BAND FALL SPONTANEOUSLY. IN THIS CASE, WHEN THE BAND AND THE NECROSED VARIX FELL FROM THE ESOPHAGUS, THE HEALING WAS NOT DONE AND THE PATIENT BLED. OTHER THAN THE DEPLOYED BANDS, A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED MAJOR HEMORRHAGES. THE PATIENT WAS HOSPITALIZED IN INTENSIVE CARE FOR AN EXTENDED STAY.

  Patient problems: Gastrointestinal Hemorrhage; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10387952 ↗
• InjuryAug 10, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. POST PROCEDURE, THE PATIENT EXPERIENCED MAJOR HEMORRHAGES WHEN PRESSURE ULCERS FELL OFF AFTER IV LIGATION. THE PATIENT HAD TO BE HOSPITALIZED IN INTENSIVE CARE FOR AN EXTENDED STAY. ADDITIONAL INFORMATION RECEIVED ON 22-JULY-2020 STATED: THEY DIDN¿T CHANGE MEDICAL TREATMENT (ANTICOAGULATION¿) FOR PATIENT. ADDITIONAL INFORMATION RECEIVED ON 27-AUGUST-2020 STATED: THIS IS NOT A BAND SLIP OFF [BAND DID NOT SLIP OFF VARIX], AS THE EVENT OCCURRED SEVERAL DAYS AFTER DELIVERY. THE DOCTOR EXPLAINED THAT HEMORRHAGES OCCURRED WHEN THE VARIX WAS OCCLUDED AND NECROSED DUE TO THE BAND. THE NORMAL PATHWAY AT THIS STAGE IS THAT THE VARIX AND BAND FALL SPONTANEOUSLY. IN THIS CASE, WHEN THE BAND AND THE NECROSED VARIX FELL FROM THE ESOPHAGUS, THE HEALING WAS NOT DONE AND THE PATIENT BLED. OTHER THAN THE DEPLOYED BANDS, A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED MAJOR HEMORRHAGES. THE PATIENT WAS HOSPITALIZED IN INTENSIVE CARE FOR AN EXTENDED STAY.

  Patient problems: Gastrointestinal Hemorrhage; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10387931 ↗
• InjuryAug 10, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. POST PROCEDURE, THE PATIENT EXPERIENCED MAJOR HEMORRHAGES WHEN PRESSURE ULCERS FELL OFF AFTER IV LIGATION. THE PATIENT HAD TO BE HOSPITALIZED IN INTENSIVE CARE FOR AN EXTENDED STAY. ADDITIONAL INFORMATION RECEIVED ON 22-JULY-2020 STATED: THEY DIDN¿T CHANGE MEDICAL TREATMENT (ANTICOAGULATION) FOR THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 27-AUGUST-2020 STATED: THIS IS NOT A BAND SLIP OFF [BAND DID NOT SLIP OFF VARIX], AS THE EVENT OCCURRED SEVERAL DAYS AFTER DELIVERY. THE DOCTOR EXPLAINED THAT HEMORRHAGES OCCURRED WHEN THE VARIX WAS OCCLUDED AND NECROSED DUE TO THE BAND. THE NORMAL PATHWAY AT THIS STAGE IS THAT THE VARIX AND BAND FALL SPONTANEOUSLY. IN THIS CASE, WHEN THE BAND AND THE NECROSED VARIX FELL FROM THE ESOPHAGUS, THE HEALING WAS NOT DONE AND THE PATIENT BLED. OTHER THAN THE DEPLOYED BANDS, A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED MAJOR HEMORRHAGES. THE PATIENT WAS HOSPITALIZED IN INTENSIVE CARE FOR AN EXTENDED STAY.

  Patient problems: Gastrointestinal Hemorrhage; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10387918 ↗
• InjuryJul 28, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. POST PROCEDURE, THE PATIENT EXPERIENCED MAJOR HEMORRHAGES WHEN PRESSURE ULCERS FELL OFF AFTER IV LIGATION. THE PATIENT HAD TO BE HOSPITALIZED IN INTENSIVE CARE FOR AN EXTENDED STAY. ADDITIONAL INFORMATION RECEIVED ON 22-JUL-2020 STATED: THEY DIDN¿T CHANGE MEDICAL TREATMENT (ANTICOAGULATION¿) FOR PATIENT. THEY WILL TRY WITH ANOTHER DEVICE (MBL-U-6) AND LET US KNOW IF NEW INCIDENTS OCCURS. A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED MAJOR HEMORRHAGES. THE PATIENT WAS HOSPITALIZED IN INTENSIVE CARE FOR AN EXTENDED STAY.

  Patient problems: Gastrointestinal Hemorrhage; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10333720 ↗
• InjuryJul 28, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. POST PROCEDURE, THE PATIENT EXPERIENCED MAJOR HEMORRHAGES WHEN PRESSURE ULCERS FELL OFF AFTER IV LIGATION. THE PATIENT HAD TO BE HOSPITALIZED IN INTENSIVE CARE FOR AN EXTENDED STAY. ADDITIONAL INFORMATION RECEIVED ON 22-JUL-2020 STATED: THEY DIDN¿T CHANGE MEDICAL TREATMENT (ANTICOAGULATION¿) FOR PATIENT. THEY WILL TRY WITH ANOTHER DEVICE (MBL-U-6) AND LET US KNOW IF NEW INCIDENTS OCCURS. A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED MAJOR HEMORRHAGES. THE PATIENT WAS HOSPITALIZED IN INTENSIVE CARE FOR AN EXTENDED STAY.

  Patient problems: Gastrointestinal Hemorrhage; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10333653 ↗
• InjuryJul 28, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. POST PROCEDURE, THE PATIENT EXPERIENCED MAJOR HEMORRHAGES WHEN PRESSURE ULCERS FELL OFF AFTER IV LIGATION. THE PATIENT HAD TO BE HOSPITALIZED IN INTENSIVE CARE FOR AN EXTENDED STAY. ADDITIONAL INFORMATION RECEIVED ON 22-JUL-2020 STATED: THEY DIDN¿T CHANGE MEDICAL TREATMENT (ANTICOAGULATION¿) FOR PATIENT. THEY WILL TRY WITH ANOTHER DEVICE (MBL-U-6) AND LET US KNOW IF NEW INCIDENTS OCCURS. A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED MAJOR HEMORRHAGES. THE PATIENT WAS HOSPITALIZED IN INTENSIVE CARE FOR AN EXTENDED STAY.

  Patient problems: Gastrointestinal Hemorrhage; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10333594 ↗
• InjuryJul 27, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. POST PROCEDURE, THE PATIENT EXPERIENCED MAJOR HEMORRHAGES WHEN PRESSURE ULCERS FELL OFF AFTER IV LIGATION. THE PATIENT HAD TO BE HOSPITALIZED IN INTENSIVE CARE FOR AN EXTENDED STAY. ADDITIONAL INFORMATION RECEIVED ON 22-JUL-2020 STATED: THEY DIDN¿T CHANGE MEDICAL TREATMENT (ANTICOAGULATION¿) FOR PATIENT. THEY WILL TRY WITH ANOTHER DEVICE (MBL-U-6) AND LET US KNOW IF NEW INCIDENTS OCCURS. A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED MAJOR HEMORRHAGES. THE PATIENT WAS HOSPITALIZED IN INTENSIVE CARE FOR AN EXTENDED STAY.

  Patient problems: Gastrointestinal Hemorrhage; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10330049 ↗