Karl Storz Warned on CAPA, Disinfection Problems

Karl Storz Endovision was handed an FDA warning letter for cleaning slips and other GMP issues related to its endoscopes.

During an Oct. 14-29 inspection of the company’s Charlton, Mass., facility, an operator failed to use the specified brush for cleaning the intubation scope in returned endoscopes. The brush being used “did not fit through the working channel,” according to the Dec. 8 letter. The device was then processed through the plant’s decontamination station, and the associated paperwork was stamped “decontaminated,” the letter says.

An investigator with the FDA’s New England district office noted that a reference document used in the cleaning/high-level disinfection area did not reference the appropriate brush models for cleaning endoscopes.

The company also lacked design validation data showing that the cleaning brush specified in its instruction manual is appropriate for a particular model of the Flex-X2 flexible ureteroscope.

The FDA found Karl Storz’s CAPAs were also deficient. For example a CAPA was opened in August 2013 to verify process control parameters in the shaft composite assembly procedure. The company’s corrective action was an operational qualification to determine the appropriate oven settings, but data in the operational qualification noted that certain replicates fell short of the peel force acceptance criteria, the warning letter says.

Moreover, the report determined that an external factor may have caused the failures but did not provide an additional explanation. The CAPA was closed in November 2013 and pointed to the operational qualification as proof of its effectiveness.

Complaints were also a problem, the letter shows. A complaint received in September referred to “a small white foreign body” in a kidney during a stone removal procedure and noted the endoscope was missing a small white piece from the tip. “As of October 29, 2014, your investigation of this complaint did not include a review of the device history record for the device, as required by your complaint procedure,” the letter says.

Another complaint, from August, referenced a problem with a cleaning brush. But Karl Storz’ investigation did not reference a similar defect trend from a 2013 CAPA. “This specific CAPA was closed on September 12, 2013, but noted that it should be referenced for any future complaints involving a cleaning brush issue,” the FDA says.

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