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A common medical device, a duodenoscope, remains a vector for harm and injury for unsuspecting patients.

A duodenoscope is a specialized form of endoscope.  An endoscope is a commonly used medical device with a flexible tube, light, and camera that is used to investigate various regions of the body.  Endoscopes can also be used to obtain tissue samples.  A duodenoscope is a device used by physicians to view the duodenum, or small intestine.

According to the US Food & Drug Administration  (FDA), duodenoscopes are used in more than a half million procedures, such as endoscopic retrograde cholangiopancreatography (ERCP).  ERCP is a method by which specialists can view and treat issues involving the liver or pancreas. In 2013, the Centers for Disease Control and Prevention (CDC) identified a possible connection between duodenoscopes and drug resistant bacteria.  Further investigation revealed that duodenoscopes were a source of cross-contamination among patients even though the devices are maintained and sterilized in accord with manufacturer instructions.

As a result, some manufacturers altered the design of duodenoscopes to use disposable parts that might harbor dangerous bacteria.  The result? For one manufacturer, disposable parts introduced to reduce risk of contamination have resulted in a warning letter from the FDA about the new parts.

In a letter to Tokyo-based Olympus Medical Systems Corp., the FDA outlined a series of violations and the response of the company to those allegations. Among the concerns:

  • The FDA has received 160 complaints noting that the end cover of the duodenoscope “dropped out.”  Media reports describe the end cover as cone-shaped pieces that have fallen into the internal organs or mouths of patients, sometimes leading to internal bleeding when the edges of the cover cut into tissue. In one instance, a defective cover lacerated the esophagus of a patient.
  • The FDA outlined concerns about the response of the company when it had been alerted to the potential hazard of the shedding of device parts in human bodies. Olympus Medical had noted that they would “continue to monitor complaints for the distal cap falling off in the patient” as its response to the FDA.
  • The warning letter faults the company for packaging failures that could impact sterility, and faults the manufacturer for its response to that concern.

The extensive warning later provided time for the company to correct its response and address the deficiencies outlined by the FDA. 

For unsuspecting patients, the loss of device parts within their body or injury because of a defective part is a terrible, potentially dangerous surprise.  If you, or a loved one, suffers serious injury due to medical mistake or a defective medical device, speak with our legal team about your concerns.

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