Hemospray Endoscopic Hemostat

Description of Event or Problem

During an endoscopic hemostasis procedure, the physician used a Cook Hemospray Endoscopic Hemostats. It was reported that the physician and team attempted to use this product during an emergency procedure; however, it did not function as intended "[unable to spray powder]". This caused significant disruption and stress for the clinical team, and they were ultimately required to use an alternative device to complete the procedure. The staff involved are highly trained and experienced in the use of this product. Therefore, they believe the issue may be due to a fault with the device supplied.At the time of this report, our attempts to collect additional information regarding patient outcome have been unsuccessful. While the complainant did not specify if the patient experienced any adverse effects, it was required to use an alternative device to complete the procedure. The information able to be collected does not reasonably suggest the patient was adversely impacted. Additional attempts to gather this information will be made.

Additional Manufacturer Narrative

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. A photo of the product labeling was provided and reviewed. The lot number in the photo matches this report. The label in the photo matches the product reported.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. 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.