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  "documentTitle": "PROCEPT BioRobotics Corporation (PRCT)",
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  "authorName": "Spruce Point Capital Management",
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  "presentationDate": "2025-01-16 00:00:00",
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  "notes": "The slide uses a red box to highlight the spike in malfunctions post-Q3 2023.",
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      "kind": "callout",
      "text": "Did Procept ship product that also should have been scrapped?",
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      "text": "The previous study covered MAUDE data through 2021. Our review from 2018 to the present shows Aquablation has resulted in 24 deaths since FDA approval. Moreover, FDA adverse event data suggests Procept's transfer of manufacturing operations to a new location in Q3 2023 resulted in above-trend equipment malfunctions, suggesting poor execution at patients' expense.",
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      "text": "Procept Adverse Events: Equipment Malfunction",
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      "text": "Adverse Events: 24",
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      "text": "The previous study covered MAUDE data through 2021. Our review from 2018 to the present shows Aquablation has resulted in 24 deaths since FDA approval. Moreover, FDA adverse event data suggests Procept's transfer of manufacturing operations to a new location in Q3 2023 resulted in above-trend equipment malfunctions, suggesting poor execution at patients' expense.",
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      "text": "…we incurred an approximate 35% increase in scrap when producing units compared to the third quarter of 2023.",
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      "text": "“...we incurred an approximate 35% increase in scrap when producing units compared to the third quarter of 2023.” — Procept CFO Waters on Q4 2023 Earnings Call",
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      "text": "Source: FDA Manufacturer and User Facility Device Experience (MAUDE) Database, Procept press release dated 9/20/23, Procept Q4 2023 earnings call transcript",
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      "text": "Reported Procept Adverse Events by Quarter table",
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      "text": "Our Deeper Dive Into FDA Adverse Event Reports Raises Concerns",
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