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

Model Number	G21049
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continued: e1: country: canada postal code: (b)(6).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.The user described the following failure to spray: "when they went to disconnect the co2 it then appeared to have the hissing noise like it was releasing co2 and the cannister then became cold, not when it was engaged." this, being interpreted as occurring when deactivating the red activation knob, is a result of the rapid release of co2 as the device depressurizes as intended during deactivation which will often be accompanied by an audible hiss, a decrease in temperature of the cartridge, and deposition of frost on the surface of the cartridge.While we are unable to determine a definitive root cause for the inability to spray experienced, it does indicate that the co2 cartridge had been punctured during device activation as intended.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.
Event or Problem Description
In preparation for a procedure, the user selected a cook hemospray endoscopic hemostat.It was reported that they prepared it as they normally would, but there was no deployment of powder.They engaged the cylinder of co2 [carbon dioxide] but there was no powder.When they went to disconnect the co2 it then appeared to have the hissing noise like it was releasing co2 and the cannister then became cold, not when it was engaged.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 (COOK ENDOSCOPY); 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): WILSON-COOK MEDICAL INC (COOK ENDOSCOPY); 4900 bethania station rd; winston-salem
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem ; 3367440157
• MDR Report Key: 21410921
• Report Number: 1037905-2025-00141
• Device Sequence Number: 9576173
• Product Code: QAU
• UDI-Device Identifier: 00827002210493
• UDI-Public: (01)00827002210493(17)270906(10)W4868237
• Combination Product (Y/N): N
• 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): 02/18/2025

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: G21049
• Device Catalogue Number: HEMO-10
• Device Lot Number: W4868237
• 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: 01/23/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown