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	04/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an endoscopic hemostasis procedure for a gi bleed, the physician used a cook hemospray endoscopic hemostat.It was reported that the tech went to activate the hemospray and it did not propel the powder [unable to spray - subject of report].Then they went to use a second hemospray and that one failed in the exact same way.The procedure was finished without the use of the hemospray.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 performed only by the picture provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photo provided we cannot complete a full evaluation.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on statements and photo describing the event.In the photo provided the 2 reported devices are shown, with the on/off switch in the "off" position, viewing the device nozzles.1 of the 2 devices appears to contain a build up of powder, while the other nozzle does not display the same build up.Powder is visible on the exterior of both devices.A photo of the lot number was not provided.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 evaluation of the photo provided could not confirm the report.In addition, 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.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 regarding this report: a cook representative has stated they will 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: 25233722
• Report Number: 1037905-2026-00240
• Device Sequence Number: 16012056
• Product Code: QAU
• UDI-Device Identifier: 00827002565722
• UDI-Public: (01)00827002565722(17)280730(10)W4959602
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/20/2026

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: W4959602
• 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: 04/26/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCOPE - UNKNOWN MAKE OR MODEL.
• Patient Age: 74 YR
• Patient Sex: Female