September 8, 2019

According to a MAUDE Adverse Event Report filed during this past summer by Hota Corporation Pentax Tokyo Office (“Pentax Medical”), “Pentax medical became aware of a report on 26-jun-2019 stating that the forward water jet channel on three customer-owned pentax medical gastroscopes model eg29-i10 (serial (b)(4)) were not cleaned or reprocessed in accordance with the pentax reprocessing instructions for use (rifu) … The facility communicated that the three customer-owned eg29-i10 gastroscopes were removed from service and quarantined at the facility since (b)(6) 2019 and that the devices were not used on additional patients after that date. The facility also communicated that foreign liquid was evacuated from at least one of the devices upon flushing the forward water jet channel.”

“Based on the facility electronic health records, pentax was informed that the 3 facility-owned devices and 1 pentax-owned loaner device were used in a total of 998 procedures … Pentax service completed an in-service with the facility on 28-jun-2019 for gastroscope model eg29-i10. During the in-service, the pentax service trainer documented the facility’s use of a boston scientific enzymatic detergent that was not evaluated for compatibility with pentax endoscopes and endochoice cleaning brushes that were not validated for use with pentax endoscopes.”

“The pentax global chief clinical officer visited the facility on 02-jul-2019 and met with the facility leadership team. Documentation from the on-site in-service was provided to the facility and the facility communicated plans to notify patients and initiate changes to its reprocessing procedures. Pentax notified fda about the incident on (b)(6) 2019. The sampling performed on (b)(6) 2019 yielded the following results: operation channel – no growth; study number (b)(6); forward water jet channel – (1) negative rods – cupriavidus species, (2) negative rods – stenotrophomonas pavanii/ pseudomonas geniculate; study number (b)(6). Because of delayed delivery and testing of the (b)(6) sample, the operation channel and forward water jet channel were resampled on (b)(6) 2019, prior to repairs. Results from the microbiological re-culturing are pending. There have been no reports of patient infection or death from this event. This mdr is one of 998 that are being filed in relation to an incident reported at a single hospital.”


What Is A Gastroscope?

A gastroscopy (examination of the stomach) can help confirm or rule out the presence of medical conditions like gastritis or peptic ulcers. In this procedure, an instrument called a gastroscope is used to look at the inside of the food pipe, the stomach, and part of the duodenum (the first part of the intestine).

A gastroscope is a flexible tube that has a small light and a video camera attached to the end of it. The images from the video camera are sent to a screen. The tube can be used to take tissue samples by inserting instruments such as small pincers. It can also be used to suck out air and fluids.


If you or a loved one were harmed as a result of a contaminated gastroscope in Oklahoma or in another U.S. state, you should promptly consult with an Oklahoma medical malpractice lawyer, or a medical malpractice lawyer in your state, who may investigate your possible claim for you and represent you or your loved one in a claim for compensation due to the injuries you suffered, if appropriate.

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