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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an endoscopic hemostasis procedure in the gastric antrum, the physician used a cook hemospray endoscopic hemostat.It was reported that the pump on device was defective.Used another of the same device and it worked perfectly.Additional information per cook district manager received on (b)(6) 2026: they setup the hemospray per the steps in the ifu, activated co2 [carbon dioxide] cartridge by turning the red activation knob until it stopped, attached catheter to the handle, turned the red on/off valve to the open position parallel with the direction of the spray, and then pressed the red trigger button for two (2) seconds but no powder was deployed.They pressed the red trigger button for two (2) seconds again, and still no powder was deployed.They confirmed that the red on/off valve was in the open position, pressed the red trigger button for two (2) seconds, and still no powder was deployed.They removed the catheter from the endoscope, pointed the catheter in a safe direction and pressed the red trigger button for two (2) seconds and no powder was deployed and no co2 was felt exiting the catheter.At this point, they opened a new hemospray, setup the device per the steps in the ifu, and the device worked properly.They were able to deploy the hemospray powder onto the gastric ulcer bleed and achieve hemostasis.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: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The additional information indicates that the second provided catheter was not utilized.The instructions for use note: "if catheter becomes occluded, turn red valve to closed position, remove catheter from endoscope and replace with extra catheter provided in package." 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.

• 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: 25430834
• Report Number: 1037905-2026-00268
• Device Sequence Number: 10373645
• Product Code: QAU
• UDI-Device Identifier: 00827002565722
• UDI-Public: (01)00827002565722(17)290323(10)W5017499
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K200972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G56572
• Device Catalogue Number: HEMO-7
• Device Lot Number: W5017499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown