Bleeding after suction rectal biopsy with Rbi2: identification of the root cause through a multi-staged approach

INTRODUCTION: Suction rectal biopsy (SRB) is a key diagnostic tool in Hirschsprung’s disease. The original Noblett device has been superseded by modern alternatives including the Rbi2 rectal biopsy gun. We describe a comparison of biopsy results from the Noblett device and the Rbi2 gun and an investigation into significant post-biopsy bleeding episodes with the latter. METHODS: A retrospective review of SRB episodes between 2006 and 2014 was undertaken to audit biopsy success rates. Significant post-procedure bleeding after SRB with the Rbi2 gun prompted further investigations. RESULTS: Biopsies taken with the Noblett gun were more likely to be inadequate (Noblett 82/197 (40%) vs Rbi2 77/438 (18%)). After biopsy with the Rbi2 gun, 2 infants suffered from significant bleeding requiring resuscitation, blood product support and multiple theater episodes. As there were no reported cases of bleeding with the Rbi2 gun, a report was made to the Medicines & Healthcare products Regulatory Agency who identified incorrect biopsy technique as a potential contributing factor. A questionnaire of trainees and consultants found unexpected individual variation in SRB technique, with some users applying excessive suction. CONCLUSIONS: Significant bleeding occurred after SRB with the Rbi2 gun, excessive suction was thought to be the cause.