Hemospray G21049Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 00827002210493), received between Jun 28, 2018 and May 21, 2026 — classified as 1 death, 3 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (49 reports).

3 FDA recall records name this device's identifier, 3 still open.

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 18, 2026.

Recalls naming this device

1. Aug 20, 2026Class IIOpen, Classified

   Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).

   Z-3177-2026 · Root cause: Labeling design · Recall details · FDA record ↗

2. Aug 29, 2024Class IIOpen, Classified

   Specific lots of product have been manufactured with nonconforming raw materials.

   Z-0036-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. May 22, 2023Class IIOpen, Classified

   There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.

   Z-1979-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Fracture

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT AFTER ACTIVATION OF CO2 [CARBON DIOXIDE] CARTRIDGE AND HEMOSPRAY WAS IN POSITION WITH VALVE TO FIRE POSITION ONCE TRIGGER WAS PRESSED CO2 CARTRIDGE SHOT OUT OF THE END WITH RED ACTIVATION KNOB. QUESTIONED STAFF AND THEY ASSURED ME CARTRIDGE WAS FULLY ENGAGED PRIOR TO PUSHING TRIGGER. ANOTHER HEMOSPRAY KIT WAS USED 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 25242750 ↗
• MalfunctionMay 13, 2026Obstruction of Flow; Activation Failure

  DURING AN ENDOSCOPIC HEMOSTASIS PROCEDURE IN THE STOMACH, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THE DEVICE FAILED TO TRIGGER [UNABLE TO SPRAY - SUBJECT OF REPORT]. A STOMACH HEMORRHAGE NEEDED TO BE STOPPED. AFTER PREPARING THE HEMOSPRAY FOLLOWING THE IFU (INTRAVENOUS FLUID ADMINISTRATION), THE HEMOSPRAY WAS TO BE TRIGGERED. A VERY SMALL AMOUNT OF POWDER WAS RELEASED. THEN NOTHING MORE. THE CATHETER WAS CHECKED AND FOUND TO BE CLEAR. THE DEVICE WAS REMOVED. WHEN THE HANDLE WAS OPENED, ONLY A FAINT HISSING SOUND WAS AUDIBLE (NORMALLY MUCH LOUDER). ANOTHER HEMOSPRAY WAS OPENED, AND THE PATIENT WAS TREATED. 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 25159544 ↗
• MalfunctionJan 30, 2026Activation Failure

  DURING AN ENDOSCOPIC HEMOSTASIS PROCEDURE IN THE STOMACH, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT WHEN ACTIVATING, IT WAS NOT CLICKING AS USUAL AND WHEN SPRAYING CLUMPS [POWDER] CAME OUT IN CLUMPS. 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 24221009 ↗
• MalfunctionSep 2, 2025Activation Failure; Activation Failure

  DURING AN OESOPHAGOGASTRODUODENOSCOPY (OGD), THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT AFTER DEPLOYMENT, THE RED VALVE WAS OPENED, THEN RED TRIGGER BUTTON WAS PRESSED FOR 1-2 SECS, NO POWDER WAS SPRAYED. THE VALVE WAS CLOSED AND CATHETER WAS REMOVED FROM WORKING CHANNEL AND SWAPPED WITH SPARE CATHETER AND DEPLOYED AND NO POWDER WAS SPRAYED WHEN VALVE WAS OPENED AND RED TRIGGER BUTTON WAS PRESSED. THE VALVE CLOSED AND CATHETER WAS REMOVED FROM SCOPE AND DETACHED FROM HEMOSPRAY AND VALVE WAS OPENED AND RED TRIGGER BUTTON WAS PRESSED AND STILL NO POWDER WAS SPRAYED. [UNABLE TO SPRAY-SUBJECT OF REPORT] A SECTION OF THIS DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT WAS NOT HOSPITALIZED AND DID NOT UNDERGO PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22938993 ↗
• MalfunctionAug 25, 2025Activation Failure; Activation Failure

  DURING AN UPPER ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THE NURSE ACTIVATED THE HANDLE, FLUSHED THE CHANNEL, AND INTRODUCED THE DEVICE DOWN THE SCOPE. WHEN PRESSING THE BUTTON NO CO2 [CARBON DIOXIDE] CAME OUT. THEY DID NOT CHANGE CATHETERS AS NO CO2 CAME OUT, SO ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE NURSE OBSERVED THAT THE HANDLE OF THE SECOND DEVICE THAT WORKED WAS COLD WHEN SPRAYING AND THE HEMOSPRAY THAT DID NOT WORK THE "HANDLE WAS NOT COLD AS IT NORMALLY IS." [UNABLE TO SPRAY-SUBJECT OF REPORT]. A SECTION OF THIS DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT WAS NOT HOSPITALIZED AND DID NOT UNDERGO PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890006 ↗
• MalfunctionJul 23, 2025Activation Failure; Activation Failure

  DURING AN ENDOSCOPIC PROCEDURE FOR AN UPPER GASTROINTESTINAL BLEED, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED "AFTER THEY SETUP AND ACTIVATE THE DEVICE (PER IFU), THEY PASSED THE CATHETER DOWN THE SCOPE CHANNEL (THUMB/PLUG TECHNIQUE, AIR FLUSH SCOPE CHANNEL ETC.), WHEN THEY PRESS DEPLOYMENT BUTTON, NO POWDER COMES OUT. THEY TRIED THE SECOND CATHETER (REPEAT STEPS), STILL NO POWDER COMING OUT. THEY REMOVED CATHETER FROM THE SCOPE, DISCONNECT THE CATHETER FROM THE HEMOSPRAY HANDLE, WITH SAFETY OFF, THEY TRIED TO SPRAY SOME IN THE TRASH BIN TO TEST BUT STILL NO POWDER COMING OUT. THEY SAID THAT THE HANDLE FELT COLD, THE PART WHERE THE CO2 CARTRIDGE IS." [UNABLE TO SPRAY-SUBJECT OF REPORT]. NO UNINTENDED SECTION OF THIS DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT WAS NOT HOSPITALIZED AND DID NOT UNDERGO PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22578138 ↗
• MalfunctionJun 9, 2025Activation Failure; Activation Failure

  DURING AN ENDOSCOPIC PROCEDURE FOR A DUODENAL ULCER AND GASTROINTESTINAL TRACT BLEEDING, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT WHEN PERFORMING HEMOSTATIC POWDER RELEASE SHOTS, THE POWDER DOES NOT SHOOT INTO THE GASTRIC CAVITY [UNABLE TO SPRAY - 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 22170161 ↗
• MalfunctionMay 15, 2025Activation Failure; Activation Failure

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THE HEMOSPRAY DID NOT WORK PROPERLY. NO CO2 WOULD SPRAY [SUBJECT OF REPORT]. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE 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 22025421 ↗
• MalfunctionMay 7, 2025Fracture; Fracture

  THE COOK SALES REPRESENTATIVE WAS CONDUCTING TRAINING DEMONSTRATIONS OF THE HEMOSPRAY DEVICE. THERE WERE NO PATIENTS INVOLVED. IT WAS REPORTED THAT THE DOCTOR WANTED TO ACTIVATE THE CO2 CYLINDER WITH SCREWING THE RED HANDLE [ACTIVATION KNOB] PART IN. THEN THE RED PART BROKE. PER THE SALES REPRESENTATIVE, THIS WAS NOT THE FIRST TIME THE HANDLE AND ACTIVATION KNOB WERE USED, AND IT WAS IDLE AND ACTIVATED FOR AN EXTENDED PERIOD OF TIME PRIOR TO THE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977600 ↗
• MalfunctionApr 22, 2025Activation Failure; Activation Failure

  DURING AN ENDOSCOPIC PROCEDURE TO TREAT AN UNKNOWN BLEED, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT HEMOSPRAY DEVICE WOULD NOT SPRAY. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO UNINTENDED SECTION OF THIS DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT WAS NOT HOSPITALIZED AND DID NOT UNDERGO PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882730 ↗
• MalfunctionMar 7, 2025Fracture; Fracture

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT DURING ACTIVATION, THE RED LEVER [ACTIVATION KNOB] BROKE AND THE GAS CARTRIDGE WAS PUSHED OUT. PHOTOS WERE PROVIDED THAT SHOW THE ACTIVATION KNOB OF THE DEVICE BROKEN AT THE INTERNAL THREADS. THIS OCCURRED PRIOR TO PATIENT CONTACT. 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. ADDITIONAL ATTEMPTS TO GATHER THIS INFORMATION WILL BE MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21548703 ↗
• MalfunctionFeb 19, 2025Activation Failure; Activation Failure

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THEY PREPARED IT AS THEY NORMALLY WOULD, BUT THERE WAS NO DEPLOYMENT OF POWDER. THEY ENGAGED THE CYLINDER OF CO2 [CARBON DIOXIDE] BUT THERE WAS NO POWDER. WHEN THEY WENT TO DISCONNECT THE CO2 IT THEN APPEARED TO HAVE THE HISSING NOISE LIKE IT WAS RELEASING CO2 AND THE CANNISTER THEN BECAME COLD, NOT WHEN IT WAS ENGAGED. 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 21410921 ↗
• MalfunctionJan 22, 2025Fracture; Fracture

  DURING AN UPPER ENDOSCOPIC PROCEDURE TO TREAT AN UPPER GI VISCERAL BLEED, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED WHEN ACTIVATING AND TURNING THE KNOB, THE MEDICAL STAFF HEARD A LOUD POP AND THE CO2 GAS ESCAPED. THE CATHETER HAD CONTACTED THE ENDOSCOPE. THE DISTRICT MANAGER CONFIRMED WITH THE END USER THAT THE DEVICE DID NOT EXPLODE, ONLY THE GAS ESCAPED. 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: Gastrointestinal Hemorrhage

  MAUDE report 21207605 ↗
• MalfunctionJan 3, 2025Activation Failure; Activation Failure

  DURING AN GASTRIC ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED "WE USED THE COOK HEMOSPRAY, IT MISFIRED". IT DID NOT DISPENSE [SPRAY] WHEN THE DEVICE WAS DEPLOYED. 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 21072750 ↗
• InjuryDec 27, 2024Activation Failure; Activation Failure

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THEY WANTED TO USE THE PRODUCT BUT WHEN THEY DID THE FIRST STEP "ACTIVATING THE SPRAY" IT JUST MADE A LOUD HISS SOUND AND THEN NO PRODUCT WAS COMING OUT. AFTER THE SYSTEM FAILED, THEY HAD TO USE ADRENALIN INJECTIONS, WHICH DID NOT WORK TO WELL. THIS OCCURRED PRIOR TO PATIENT CONTACT. 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: Gastrointestinal Hemorrhage; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028027 ↗
• MalfunctionNov 15, 2024Obstruction of Flow; Activation Failure; Obstruction of Flow; Activation Failure

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THE HEMOSPRAY POWDER WAS NOT ABLE TO SPRAY OUT AFTER ACTIVATION OF CO2 [CARBON DIOXIDE] GAS. THE USER CHANGED TO ANOTHER ONE IMMEDIATELY WHICH IS ABLE TO WORK WELL. 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 20699719 ↗
• MalfunctionNov 15, 2024Activation Failure; Activation Failure

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE TO TREAT BLEEDING IN THE STOMACH, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THEY WANTED TO USE THE HEMOSPRAY AS THEY ALWAYS DO, BUT THIS TIME THERE WAS WAY LESS POWER (PRESSURE) IN THE SYSTEM, WHICH LEAD TO ALMOST NO SUBSTANCE [POWDER] AT THE BLEEDING SIDE [SITE]. 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 20695757 ↗
• MalfunctionNov 12, 2024Fracture; Fracture

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT DURING THE SET UP OF THE DEVICE, THERE WAS A LOUD BANG AND CO2 [CARBON DIOXIDE] DISCHARGED. HEMOSPRAY WOULD NOT DEPLOY. THIS OCCURRED PRIOR TO PATIENT CONTACT. 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 20667893 ↗
• MalfunctionOct 24, 2024Fracture; Fracture

  IN PREPARATION FOR AN ENDOSCOPIC PROCEDURE TO TREAT AN EGD BLEED, THE PHYSICIAN SELECTED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT WHILE TWISTING THE ACTIVATION KNOB, THE CO2 [CARBON DIOXIDE] EXPLODED AND THE HANDLE SHOT OFF AND HIT THE DOCTOR IN THE BELLY. THE DOCTOR DID NOT REQUIRE MEDICAL ATTENTION FOR THIS. THEY SUCCESSFULLY COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE OF SOME TYPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT OR USER 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: Pain

  MAUDE report 20522850 ↗
• MalfunctionSep 19, 2024Fracture; Fracture

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO TREAT AN ACTIVE BLEED IN THE STOMACH AND DUODENAL BULB, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE TECH STATED WHEN HE ACTIVATED THE DEVICE, THERE WAS A LOUD AIR POP AND HE HELD THE DEVICE AS TIGHT AS HE COULD TO STOP IT FROM EXPLODING. HE DESCRIBED THE FORCE AS ¿VERY AGGRESSIVE AND HARD TO CONTAIN¿, HIS HAND TOOK THE BRUNT OF THE FORCE, AND NO SERIOUS INJURY OCCURRED. PER THE COOK SALES REP, THE ACTIVATION KNOB WAS MISSING THE THREADING ON THE INSIDE AND THE PLASTIC WAS VISIBLY CRACKED. THE PRODUCT DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE THAT DID NOT SHARE THE SAME LOT NUMBER. 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: Pain

  MAUDE report 20259079 ↗
• MalfunctionSep 6, 2024Activation Failure; Activation Failure

  DURING A PROCEDURE INVOLVING A D2 ULCER BLEEDING, THE DOCTOR ATTEMPTED TO USE A COOK HEMOSPRAY DEVICE. WHILE ACTIVATION OF THE CYLINDER, THE POWDER WAS NOT DELIVERED, TEAM WAITED FOR THE SPRAY, THEY FELT THE CYLINDER EMPTY BUT IT DID NOT DELIVER THE POWDER [UNABLE TO SPRAY - SUBJECT OF REPORT]. AS A RESULT, THEY HAD TO SWITCH TO ANOTHER OF THE 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 20163136 ↗
• MalfunctionMay 24, 2024Activation Failure; Activation Failure

  DURING AN ENDOSCOPIC PROCEDURE TO TREAT A BLEEDING ULCER IN THE STOMACH, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THE HEMOSPRAY WAS SUCCESSFULLY ACTIVATED IN THE FIRST ATTEMPT. THE FIRST APPLICATION WAS SUCCESSFUL. WHEN THE CUSTOMER APPLIED IT AGAIN TWO MINUTES LATER, THE PRESSURE ON THE HANDLE WAS RELEASED. THE CO2 ESCAPED THROUGH THE HANDLE WITH A HISS. 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 19393752 ↗
• MalfunctionMay 24, 2024Activation Failure; Activation Failure

  DURING AN ENDOSCOPIC PROCEDURE FOR A DUODENAL BULB INJURY THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT DURING THE PROCEDURE, AND AT THE BEGINNING OF THE FIRST SHOT WITH THE DEVICE, NO DUST [POWDER] CAME OUT. THE CO2 GAS CYLINDER DID NOT COME OUT [UNABLE TO SPRAY]. 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 19390118 ↗
• MalfunctionMay 17, 2024Obstruction of Flow; Activation Failure; Obstruction of Flow; Activation Failure

  DURING AN ENDOSCOPIC PROCEDURE TO TREAT A BLEEDING BULBAR ULCER IN THE STOMACH, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THE HEMOSPRAY DIDN'T WORK. NOTHING WAS RELEASED, NEITHER THE CO2 [CARBON DIOXIDE] GAS OR THE POWDER WAS RELEASED. ANOTHER OF THE SAME DEVICE WAS USED 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 19345835 ↗
• MalfunctionMay 17, 2024Activation Failure; Activation Failure

  DURING AN ENDOSCOPIC PROCEDURE TO TREAT A BLEEDING BULBAR ULCER IN THE STOMACH, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THE HEMOSPRAY DIDN'T WORK. NOTHING WAS RELEASED, NEITHER THE CO2 [CARBON DIOXIDE] GAS OR THE POWDER WAS RELEASED. ANOTHER OF THE SAME DEVICE WAS USED 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 19344925 ↗