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Description

Duodenal fistula leaking through skin defect and still open duodenal defect at 2 weeks following fistula creation by anastomosis between the skin and duodenum defect ( c )

"Your Health Hazard Evaluation (HHE) Qual-124366 dated June 11, 2024, determined the risk was low, which is inconsistent with your design failure modes and effectiveness analysis (dFMEA) (RA2022047