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

Model Number	G21049
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an esophagogastroduodenoscopy (egd), the physician used a cook hemospray endoscopic hemostat.It was reported that after activation of co2 [carbon dioxide] cartridge and hemospray was in position with valve to fire position once trigger was pressed co2 cartridge shot out of the end with red activation knob.Questioned staff and they assured me cartridge was fully engaged prior to pushing trigger.Another hemospray kit was used to complete the procedure.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 biohazard bag.Provided with the return was a tray lid stock 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.No catheters were included in the return.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 on the exterior of the returned device.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).A ring of foam was noted to be seated around the lance, but did not obstruct activation.The activation knob was found to be intact with no cracks or other damage indicative of the reported ejection of the co2.When tested with a new co2 cartridge and activation knob, and the ring of foam placed around the lance, the device was able to fully activate, with no audible leakage of co2 from the device handle.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: our evaluation of the returned device could not confirm the report as it was described.A definitive cause for the reported observation could not be determined because the activation knob was found to be intact, without evidence of co2 cartridge ejection and no leakage of co2 was observed from the handle when activated with a new co2 cartridge and activation knob.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.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: based on the quality engineering risk assessment no corrective action is warranted at this time.A review of the complaint history was conducted.Based on this review, the likelihood of this type of report is rare.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: 25242750
• Report Number: 1037905-2026-00241
• Device Sequence Number: 9490551
• Product Code: QAU
• UDI-Device Identifier: 00827002210493
• UDI-Public: (01)00827002210493(17)261003(10)W4770535
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 05/21/2026

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 Expiration Date: 10/03/2026
• Device Model Number: G21049
• Device Catalogue Number: HEMO-10
• Device Lot Number: W4770535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2023
• 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-OLYMPUS GIF1TH190
• Patient Sex: Unknown