MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC HEMOSPRAY ENDOSCOPIC HEMOSTAT; HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE

Model Number	G56572
Medical Device Problem Codes	Complete Blockage (1094); Activation Failure (3270)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
Date of Event	05/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During an endoscopic hemostasis procedure in the duodenum, the physician used a cook hemospray endoscopic hemostat.It was reported that the powder spraying was initially successful but became impossible during the procedure.The catheter was replaced due to suspected clogging; however, spraying still failed, and hemostasis could not be achieved.The procedure was completed using clips and hemostatic forceps.A section of the device did not remain inside the patient¿s body.Hemostasis was achieved using an alternate modality.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a clear plastic bag.Provided with the return was a tray lid stock from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report.All components were included in the return.Catheter #1 had residual powder at the distal end, but no kinks, discoloration, or dark accumulations of powder were noted.Catheter #2 had a darkened powder buildup within the tubing along with a reddish-brown discoloration at various locations within the catheter.The returned catheters were observed to have been cut based upon their length and lack of distal cook labeling on the catheter tubing.Under magnification the tips were noted to be uneven and deformed, further indicative of cutting.The length of the tubing of catheter #1 measured 206.8cm and catheter #2 measured 199.5cm.The device was returned with the on/off switch in the "on" position.The red activation knob was engaged in the handle indicating activation of the carbon dioxide (co2) cartridge.Powder was noted within the device nozzle, on the exterior of returned components, and within the return packaging.The device did not spray as returned.The co2 cartridge did not audibly discharge during deactivation and the cartridge was observed to be fully punctured.A visual examination of the o-ring and lance inside the handle showed both components to be positioned correctly inside the handle and the lance to be beveled.The inspection of the co2 cartridge and regulator (lance and o-ring) confirm the device was of the current design.The foam was present and in the correct orientation (slits facing the red activation knob).When tested with a new co2 cartridge and activation knob the device did not initially spray as intended.After insertion of a thin wire into the nozzle to break up possible occlusions, the device sprayed as intended.When catheter #1 was attached and spraying was attempted the device sprayed as intended.When catheter #2 was attached and spraying was attempted powder exited the nozzle before stopping at the dark buildup of powder within the catheter confirming occlusion and is the likely cause for the observed nozzle occlusion.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: our laboratory evaluation of the product said to be involved confirmed the report.One of the returned catheters was found to be occluded.Catheter occlusion can create backflow and push powder, blood, and fluid back into the device, creating an internal clog which was observed within the device nozzle resulting in the subsequent inability to spray observed by the user.However, a definitive cause for the observed catheter occlusion could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.Both of the returned catheters were noted to have been cut at the distal end.Cutting the distal catheter is not a suggested method per the instructions for use for troubleshooting, nor for alleviating catheter occlusions.The instructions for use warn: "no modification to this equipment is allowed." prior to distribution, all hemospray endoscopic hemostats are subjected to a visual inspection to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: based on the quality engineering risk assessment no corrective action is warranted at this time.A review of the complaint history was conducted.Quality assurance will continue to monitor for complaint trends.Additional comments: based on the information provided that the returned catheters have been cut, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

• Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT
• Common Device Name: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 25411056
• Report Number: 1037905-2026-00266
• Device Sequence Number: 12194294
• Product Code: QAU
• UDI-Device Identifier: 00827002565722
• UDI-Public: (01)00827002565722(17)290119(10)W5000682
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• PMA/510(K) Number: K200972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G56572
• Device Catalogue Number: HEMO-7
• Device Lot Number: W5000682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown