ClearanceBrief
Recall Z-2071-2016 ยท FDS Gastroscope And Accessories, Flexible/Rigid

Pentax Medical Company

Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth 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
Quantity9,669 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

K131902PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)
Pentax Medical Company, Apr 10, 2014
K850020PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23
Pentax Precision Instrument Corp., Jul 9, 1985
K961564EG-2940, VIDEO GASTROSCOPE
Pentax Precision Instrument Corp., Jul 9, 1996
K962460EG-3800T, VIDEO GASTROSCOPE
Pentax Precision Instrument Corp., Sep 16, 1996
K962897EG-3400, VIDEO GASTROSCOPE
Pentax Precision Instrument Corp., Oct 4, 1996