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

Catalog Number	HEMO-10
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
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 tray from the lot number provided in the report with a copy of the complaint form taped to it.The label matches the product returned.Our evaluation of the product said to be involved confirmed the report as it was described.All components were included in the return.Both catheters were included in the return and appear to be unused.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, within the device nozzle, and within the tray.When tested as returned the device sprayed a small amount of powder.Powder was noted to be swirling within the powder chamber and co2 can be heard exiting the nozzle when attempting to spray indicating that co2 is passing through the system despite the small amount of powder released.The co2 cartridge audibly discharged 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 a small amount of powder intermittently.By gently shaking the handle to address possible voids forming in the powder chamber, and compressing the button again, the flow of powder resumed and it began spraying as intended with and without one of 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 # said to be involved was reviewed.Nonconformances that could potentially be related to the complaint were contained in the associated dhr.The nonconformance documentation supports the affected device(s) were dispositioned appropriately prior to release of this lot.There is no evidence nonconforming product was released for distribution.In an effort to heighten awareness of the potential connection of the customers report to the current manufacturing processes production personnel were notified.Investigation conclusion: the laboratory evaluation of the returned device confirmed the report.The root cause for the report of unable to spray is most likely voids forming within the powder as powder was released, creating empty spaces in the chamber which disrupted the flow of powder.It was noted that the returned catheters appear to be unused indicating this device was likely used with a different catheter which was not provided in the return.Additionally, the minimum required channel size to accommodate a hemo-10 catheter is 3.7mm, the user reported they used a 2.8mm scope supporting that the returned catheters were not used during the procedure.Catheter occlusion can be a cause of this device not being able to spray powder.However, we could not conduct a complete investigation because the used catheter was not returned for evaluation.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 an endoscopic procedure for a duodenal bulb injury the physician used a cook hemospray endoscopic hemostat.It was reported that during the procedure, and at the beginning of the first shot with the device, no dust [powder] came out.The co2 gas cylinder did not come out [unable to spray].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): 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: 19390118
• Report Number: 1037905-2024-00282
• Device Sequence Number: 7799858
• Product Code: QAU
• UDI-Device Identifier: 00827002210493
• UDI-Public: (01)00827002210493(17)241015(10)W4525814
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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 Expiration Date: 10/15/2024
• Device Catalogue Number: HEMO-10
• Device Lot Number: W4525814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• 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 PENTAX 2.8MM CHANNEL
• Patient Sex: Male