MAUDE Adverse Event Report: Wilson-Cook Medical Inc Hemospray Endoscopic Hemostat; Hemostatic device for endoscopic gastrointestinal use

Model Number	G56572
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During an endoscopic gastrointestinal hemostasis procedure, the physician used a cook hemospray endoscopic hemostat.It was reported that the trigger button was pressed to deliver powder to the target site during endoscopic gastrointestinal hemostasis; however, no powder was emitted.The procedure was completed using an alternative product.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.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a clear plastic bag.Provided with the return was an open tray from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved could not confirm the report as it was described.All components were included in the return.Catheter #1 was returned attached to the device nozzle.Residual powder was noted within and on the exterior of the red catheter hub and within the distal end of the catheter.Additionally, the catheter appears to have been cut based upon the lack of distal printed text and the length of the tubing measuring shorter than specification.Catheter #2 was noted to have residual powder within and on the exterior of the red catheter hub and within the distal end of the catheter.No kinks or discoloration were observed for either of the returned catheters.The device was returned with the on/off switch in the "off" position.The red activation knob was engaged in the handle indicating activation of the carbon dioxide (co2) cartridge.Residual powder was observed within the device nozzle and on the exterior of the returned components.When tested as returned, the device did not spray as intended.When disengaging the activation knob no audible discharge of co2 was observed.The co2 cartridge was 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 oriented correctly within the handle (slits pointing down towards the red activation knob).A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.When tested with a new co2 cartridge and activation knob, the device sprayed as intended both with and without the returned catheters attached.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: the laboratory evaluation of the returned device could not confirm the report because the device sprayed as intended when tested with a new co2 cartridge and activation knob.Catheter occlusion can be a potential cause for inability to spray; however, we could not conduct a complete investigation because one of the catheters returned for evaluation had been cut and a significant portion of the length was not provided for evaluation.This limits our ability to conclusively determine a cause.It was noted that the catheter has been cut.The instructions for use state: "if catheter becomes occluded, turn red valve to closed position, remove catheter from endoscope and replace with extra catheter provided in package." additionally, the instructions for use warn "no modification to this equipment is allowed." cutting the catheter is not recommended.A corrective action (capa) was initiated to further investigate device failure due to being unable to spray powder.This device is within the scope of the capa.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: a corrective action (capa) was initiated to further investigate device failure due to being unable to spray powder.The product said to be involved is included in the scope of the corrective action.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 one of the returned catheters has 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 ; +1(336)744-0157
• MDR Report Key: 50225648
• Report Number: 1037905-2026-00407
• Device Sequence Number: 13347617
• Product Code: QAU
• UDI-Device Identifier: 00827002565722
• UDI-Public: (01)00827002565722(17)290429(10)W5027898
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 08/12/2026

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: W5027898
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown