Fracture of Bronchoscopic Biopsy Valve
Hazard [Health Devices Jan-Feb 1999;28(1-2):79]
A surgeon at a member hospital was performing a
procedure with a flexible bronchoscope when a small piece of the reusable biopsy
valve broke away and entered the patient. Removal of the piece extended the
procedure by 20 minutes.
Biopsy valves (also known as inlet seals) are not
specific to bronchoscopic procedures; rather, they are used to seal the working
channel of any type of endoscope to prevent the escape of liquids or air from
the patient. The valve involved in the incident is similar to models distributed
by all endoscope suppliers.
Any biopsy valve is subject to being torn by the
surgical instruments that are passed through it. Severe tearing may result in
portions of the valve breaking free and either obstructing the working channel
or entering the patient. In addition, some valves are designed to withstand only
a limited number of procedures. Suppliers of these "semidisposable"
valves generally specify the number of uses these devices should undergo before
they are replaced.
Following the reported incident, the supplier of the
biopsy valve informed the hospital that the maximum number of uses for that type
of valve had been exceeded. The valve was semidisposable, and the product insert
included in the packaging stated that the valve should be used for no more than
- Inspect biopsy valves before each procedure, and
dispose of those exhibiting signs of excessive wear.
- Also examine biopsy valves at the completion of the
procedure to ensure that no portions have broken free unnoticed.
- If semidisposable valves are being used, carefully monitor their use to
ensure that the maximum number of procedures outlined in the supplier's
instructions is not exceeded.
- Bronchoscopes [10-491]
- Bronchoscopes, Flexible [15-073]
Cause of Device-Related Incident
Device factor: Device failure
User errors: Failure to perform pre-use inspection;
Failure to read label
Support system failure: Lack or failure of incoming or
Mechanism of Injury or Death