OtherFAM
B-K MEDICAL
Received Dec 2, 2004 · Event occurred Nov 22, 2004
Report 559053 · MDR key 559053
Device
Generic name
Rectosigmoidoscope
Manufacturer
B-k Medical Systems Inc.Model number
DO 0163Catalog number
*
Lot number
*
Product problems
- Difficult to Remove
- Increase in Suction
- Physical Resistance
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
DOCTOR WAS USING THE RECTOSIGMOIDOSCOPE TO PROVIDE ACCESS FOR A TYPE 2050 ANORECTAL ULTRASOUND TRANSDUCER. DOCTOR NOTICED THAT WHEN ATTEMPTING TO REMOVE THE OBTURATOR, THERE WAS SIGNIFICANT RESISTANCE, INDICATING THE OBTURATOR WAS PULLING A VACUUM. DOCTOR FEELS THERE IS A RISK OF PULLING PART OF THE INTESTINE INTO THE RECTOSIGMOIDOSCOPE AND INJURING THE PATIENT.IT IS OUR OPINION THAT SOME KIND OF CHANNEL OR VENT IS NEEDED TO PREVENT A VACUUM WHEN THE OBTURATOR IS REMOVED. THERE WAS NO PATIENT INJURY.