Saeed G25240Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002252400), received between Jul 8, 2016 and Nov 30, 2020 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2020Device Dislodged or Dislocated; Material Too Soft/Flexible; Device Dislodged or Dislocated; Material Too Soft/Flexible

  DURING AN DIGESTIVE ENDOSCOPY WITH LIGATION OF ESOPHAGEAL VARICES PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE ELASTIC LIGATION KIT BANDS DID NOT SHRINK, WERE HARDENED, STRANGLING THE VARICOSE VEINS, AND COULD NOT PERFORM 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 10922754 ↗
• InjuryNov 17, 2017Migration or Expulsion of Device; Device Operates Differently Than Expected; Migration or Expulsion of Device; Device Operates Differently Than Expected

  DURING THREE (3) SEPARATE ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURES, THE PHYSICIAN USED FOUR (4) COOK 6 SHOOTER SAEED MULTI-BAND LIGATORS. ACCORDING TO A MEDICAL REPORT ON (B)(6) 2017, DURING THE ACCOMPLISHMENT OF TWO (2) PROCEDURES OF ELASTIC LIGATION OF ESOPHAGEAL VARICES IN DIFFERENT PATIENTS, FAILURE OCCURRED IN THE RELEASE OF THE ELASTIC "BANDS", WHERE MORE THAN HALF OF THEM DID NOT KEEP OBLITERATING THE VARICOSE VEINS ASPIRATED BY THE CAP [BARREL] [BANDS WERE NOT TIGHT ENOUGH] (SEE RELATED MDR 1037905-2017-00698), OR LOST IMMEDIATELY AFTER RELEASE [BANDS FALL OFF SITE PREMATURELY] (SUBJECT OF THIS REPORT). THIS FACT CAUSED IMMEDIATE HEMORRHAGIC INTERCURRENCE IN BOTH PATIENTS, SINCE AFTER THE ASPIRATION, IT WAS NOT POSSIBLE TO CONTAIN VARICOSE HEMORRHAGE, WHICH LED TO THE PHYSICIAN SHED [COMPLETING] VARICOSE SCLEROSIS WITH ETHAMOLIN. BOTH PATIENTS EVOLVED WELL AND DID NOT NEED TO REMAIN HOSPITALIZED. ON (B)(6) 2017, THE PHYSICIAN PERFORMED AN EDA (HIGH DIGESTIVE ENDOSCOPY) IN A PATIENT IN ANOTHER INSTITUTION, WITH ANOTHER DEVICE. THE PRESENCE OF LARGE CALIBER ESOPHAGEAL VARICES WITH THE PRESENCE OF HEMATOCYST WAS OBSERVED ON THE SURFACE OF A VARICOSE CORD, SUGGESTING RECEN

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hemostasis

  MAUDE report 7043467 ↗
• InjuryNov 17, 2017Migration or Expulsion of Device; Device Operates Differently Than Expected; Migration or Expulsion of Device; Device Operates Differently Than Expected

  DURING THREE (3) SEPARATE ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURES, THE PHYSICIAN USED FOUR (4) COOK 6 SHOOTER SAEED MULTI-BAND LIGATORS. ACCORDING TO A MEDICAL REPORT ON (B)(6) 2017, DURING THE ACCOMPLISHMENT OF TWO (2) PROCEDURES OF ELASTIC LIGATION OF ESOPHAGEAL VARICES IN DIFFERENT PATIENTS, FAILURE OCCURRED IN THE RELEASE OF THE ELASTIC "BANDS", WHERE MORE THAN HALF OF THEM DID NOT KEEP OBLITERATING THE VARICOSE VEINS ASPIRATED BY THE CAP [BARREL] [BANDS WERE NOT TIGHT ENOUGH] (SEE RELATED MDR 1037905-2017-00698), OR LOST IMMEDIATELY AFTER RELEASE [BANDS WERE NOT TIGHT ENOUGH] (SEE RELATED MDR 1037905-2017-00699). THIS FACT CAUSED IMMEDIATE HEMORRHAGIC INTERCURRENCE IN BOTH PATIENTS. AFTER THE ASPIRATION, IT WAS NOT POSSIBLE TO CONTAIN VARICOSE HEMORRHAGE, WHICH LED TO THE PHYSICIAN SHED [COMPLETING] VARICOSE SCLEROSIS WITH ETHAMOLIN. BOTH PATIENTS EVOLVED WELL AND DID NOT NEED TO REMAIN HOSPITALIZED. ON (B)(6) 2017, THE PHYSICIAN PERFORMED AN EDA (HIGH DIGESTIVE ENDOSCOPY) IN A PATIENT IN ANOTHER INSTITUTION, WITH ANOTHER DEVICE. THE PRESENCE OF LARGE CALIBER ESOPHAGEAL VARICES WITH THE PRESENCE OF HEMATOCYST WAS OBSERVED ON THE SURFACE OF A VARICOSE CORD, SUGGESTING REC

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hemostasis

  MAUDE report 7043390 ↗
• MalfunctionJul 8, 2016Premature Activation; Premature Activation

  ON (B)(6) 2016, THE FOLLOWING WAS REPORTED TO THE COOK: DURING AN ESOPHAGEAL VARICEAL LIGATION PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. AS REPORTED TO CUSTOMER RELATIONS: "DURING THE PROCEDURE THE DOCTOR REPORTED THE RELEASE OF THREE LEAGUES [BANDS] AT ONE GO, AFTER THE SHOOTING [PREMATURE DEPLOYMENT]." ON 09/09/16, WE RECEIVED THE ENDOSCOPE MAKE USED DURING THE PROCEDURE.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 5778670 ↗