Catalog Number HEMO-10-EU |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/28/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Information regarding- suspect medical device.Common device name: not available.Regulation name: hemostatic device for intraluminal gastrointestinal use.Information regarding: (b)(4).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 user provided a graphic of the hemospray device with the red activation knob circled, indicating it as the portion that broke during the procedure when asked for clarification.The report could not be confirmed.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.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 review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
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Event Description
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During a hemostasis procedure, the physician used a cook hemospray endoscopic hemostat.The catheter was inside the endoscope.They were starting to use the product.The carbon dioxide canister "flew off and broke the handle." the section that broke was the red area (red knob).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.
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Search Alerts/Recalls
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