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U.S. Department of Health and Human Services

Medsun Reports
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Type of Device:
Instrument, Biopsy, Suction
Device Brand Name:
rbi2 suction rectal biopsy system
Device Manufacturer's Name:
AUS SYSTEMS PTY. LIMITED.
Date of this Report:
(mm/dd/yyyy)
10/07/2024
Describe the Event
or Problem:
Suction rectal biopsy was performed successfully twice (x2). On the third attempt, after triggering the suction rectal biopsy gun, there was a clicking noise. The capsule was unable to be removed from patient's rectum and found to be stuck on rectal mucosa. MD and Pediatric Surgeon Fellow notified. She attempted to flush and probe the capsule. After about 40 minutes, it was successfully removed after patient stooled on their own. No tissue noted in cartridge on removal. No bleeding.
the device(s) may have
caused or contributed to:
Potential for patient harm
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