ClearanceBrief
Recall Z-2068-2016 ยท FDF Colonoscope And Accessories, Flexible/Rigid

Pentax Medical Company

Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

DateJun 28, 2016 (initiated Apr 6, 2016)
StatusTerminated
ReasonPentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Root causeDevice Design
ActionPentax sent an Urgent Field Correction letter dated April 6, 2016 to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were reminded to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope's instrument/suction channel and to ensure that any therapeutic devices passed through the instrument channel are accounted for after use. If the instrument/suction channel does become blocked or clogged due to the accumulation of debris, an accessory that cannot
Quantity12,412 units
DistributionWorldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K131855PENTAX VIDEO COLONOSCOPES (EC FAMILY)
Pentax Medical Company, Apr 9, 2014
K951574EC-3800L, VIDEO COLONOSCOPE
Pentax Precision Instrument Corp., Mar 21, 1996
K951578FC-38LX, FIBER COLONOSCOPE
Pentax Precision Instrument Corp., Jun 27, 1995
K951579EC-3800TL, VIDEO COLONOSCOPE
Pentax Precision Instrument Corp., Mar 21, 1996
K961570KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH)
Pentax Precision Instrument Corp., Jun 24, 1996