Cause of Device-Related Incident
Device factors; Support system failures; User errors

Clinical Specialty or Hospital Department
Anesthesia; CSR / Materials Management; OR / Surgery

Device Factors
Device failure

Document Type
Hazard Reports

External Factors
*Not stated

Mechanism of Injury or Death
Particulates

Support System Failures
Lack or failure of incoming and pre-use inspections

Tampering and/or Sabotage
*Not stated

User Errors
Failure to perform pre-use inspection; Failure to read label

UMDNS
Bronchoscopes [10-491]; Bronchoscopes, Flexible [15-073]

Fracture of Bronchoscopic Biopsy Valve



Hazard [Health Devices Jan-Feb 1999;28(1-2):79]

Problem

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.

Discussion

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 five procedures.

Recommendations

  1. Inspect biopsy valves before each procedure, and dispose of those exhibiting signs of excessive wear.
  2. Also examine biopsy valves at the completion of the procedure to ensure that no portions have broken free unnoticed.
  3. 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.

UMDNS Terms

  • 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 pre-use inspections

Mechanism of Injury or Death

Particulates

 


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