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	10/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continued: section g: 510k: k200972.The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.
Event or Problem Description
During an unknown endoscopic procedure to treat bleeding in the stomach, the physician used a cook hemospray endoscopic hemostat.It was reported that they wanted to use the hemospray as they always do, but this time there was way less power (pressure) in the system, which lead to almost no substance [powder] at the bleeding side [site].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
Continued: section g: 510k: k200972.Investigation evaluation: the product said to be involved was returned in a clear plastic bag.Provided with the return was an open tray from the lot number provided in the report.The label matches the product returned.Our evaluation of the product said to be involved could not confirm the report as it was described.Two catheters were returned.Neither of the catheters showed any signs of use (no kinks, powder within, or discoloration).The device was returned with the on/off switch in the "off" position.The red activation knob was engaged in the handle indicating activation of the carbon dioxide (co2) cartridge.No powder was observed on the exterior of the returned components or 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 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 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.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 both with and without the returned catheters attached.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.Catheter occlusion can be a cause of this device not being able to spray powder.However, the returned catheters appeared to be unused and therefore not used during the reported occurrence.We could not conduct a complete investigation as the used catheter was not returned for evaluation.This limits our ability to conclusively determine a cause.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.

• 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): COOK ENDOSCOPY; 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: 20695757
• Report Number: 1037905-2024-00729
• Device Sequence Number: 17083028
• Product Code: QAU
• UDI-Device Identifier: 00827002210493
• UDI-Public: (01)00827002210493(17)270626(10)W4849066
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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: W4849066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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
• Patient Sex: Unknown