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

Model Number	G56572
Medical Device Problem Codes	Material Twisted/Bent (2981); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a clear biohazard bag.A lot number was not provided with the returned device.Our evaluation of the product said to be involved could not confirm the report as it was described.Not all components were included in the return, neither catheter was returned, therefore a complete evaluation was not possible.The device was returned with the on/off switch in the "on" position.The red activation knob was disengaged in the handle indicating deactivation of the carbon dioxide (co2) cartridge.Powder was observed within the device nozzle, on the outside of the device, and within return packaging.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 present and in the correct orientation (slits facing the red activation knob).When tested with a new co2 cartridge and activation knob the device sprayed as intended.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: 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.The root cause for the report of unable to spray is unknown.We could not conduct a complete investigation due to the condition of the returned device said to be involved.The alleged kinked catheter was not returned for evaluation.This limits our ability to conclusively determine a cause.The build up of pressure within the system due to repeated button compressions is the likely cause for the release of powder following unkinking of the catheter with the valve in the "on"/"open" position.Prior to distribution, all hemospray endoscopic hemostats are subjected to a visual inspection and functional testing 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.
Event or Problem Description
During an endoscopic hemostasis procedure for a bleed in the diverticulum, the physician used a cook hemospray endoscopic hemostat.It was reported that while applying the powder, the powder would not come out.A kink was noted in the catheter, and the medical staff unkinked it.Then at the luer lock there was a big poof of powder, and the device ran out of co2 [unable to spray - subject of report].The second catheter was not used; the procedure was completed with another of the same device.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.

• 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: 25354681
• Report Number: 1037905-2026-00255
• Device Sequence Number: 21496404
• Product Code: QAU
• UDI-Device Identifier: 00827002565722
• UDI-Public: (01)00827002565722(17)281030(10)W4982709
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/01/2026

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: W4982709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown