KARL STORZ ENDOSCOPY-AMERICA, INC. PROTOSCOPES, SIGMOIDOSCOPES, ACC.; SIGMOIDOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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Model Number 13901NKS |
Device Problems
Break (1069); Detachment Of Device Component (1104)
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Patient Problem
No Information (3190)
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Event Date 11/10/2016 |
Event Type
malfunction
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Event Description
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While removing the video sigmoidoscope from the light source, the sigmoidoscope body separated from the light source connection and the flexible endoscope sheath.This is the second occurrence of this type of failure on this sigmoidoscope model.Review with the user indicated that they did follow correct removal procedure.This scope was the exchange scope replacing a scope that had the same damage with separation of the light connector body and flexible sheath.Manufacturer response for video sigmoidoscope, (brand not provided) (per site reporter: manufacturer noted this was a warranty device delivered two months ago.Manufacturer called unit in.Biomedical engineering is requesting report on failure.
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