MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC 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	08/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continued: section g: 510k: k200972.Investigation evaluation: the product said to be involved was returned in an open unlabeled pouch.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.All components were included in the return.Both catheters were returned, neither of the catheters were discolored, neither contained visible powder build up, and neither were kinked.The device was returned with the on/off switch in the "on" position.The red activation knob was engaged in the handle indicating activation of the carbon dioxide (co2) cartridge.Powder was observed on the outside of the device and within the device nozzle.When tested as returned the device did not spray as intended.The co2 cartridge did not audibly discharge upon deactivation and the 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 oriented correctly within the handle (slits pointing down towards the red activation knob).When tested with a new co2 cartridge and activation knob, the device sprayed as intended both with and without the returned catheters attached.Upon releasing the button after depression a small puffing noise was noted as the low pressure valve (lpv) returned to the closed position.The lpv was disassembled and, while there was a small amount of powder noted within, no anomalies were noted which would result in the reported difficulty.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.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.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 has been initiated in an effort to reduce occurrences of this nature.This product is included in the scope of this corrective action.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Event or Problem Description
During a procedure involving a d2 ulcer bleeding, the doctor attempted to use a cook hemospray device.While activation of the cylinder, the powder was not delivered, team waited for the spray, they felt the cylinder empty but it did not deliver the powder [unable to spray - subject of report].As a result, they had to switch to another of the same device 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.

• 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 ; 8002454707
• MDR Report Key: 20163136
• Report Number: 1037905-2024-00520
• Device Sequence Number: 20655784
• Product Code: QAU
• UDI-Device Identifier: 00827002210493
• UDI-Public: (01)00827002210493(17)261205(10)W4789824
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/06/2024

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: W4789824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCOPE - UNKNOWN MAKE OR MODEL.
• Patient Sex: Unknown