2 of 2 it was reported that during a routine colonoscopy procedure, the user noticed that the water irrigation appears to be causing a tear in the patient when the scope is in the cecum.The user was using the ofp-2 serial number (b)(4) along with the scope.The user stopped the irrigation, checked the patient to make sure there is no additional bleeding.The procedure was completed using the same equipment with no additional patient harm or injury reported due to the event.The subject device has not yet been received for evaluation however, during the field service engineer (fse) site visit, the ofp-2 was reported to be producing a very high pressure during the procedure.The fse inspected the flushing pump and foot switch and found no defects.The ofp-2 flushing pump with the scope and a cv-190 device system were tested together and found no issue.The fse was not able to duplicate the problem reported.Both systems tested are functional.Further inspection determined that a third party tubing was being routed through the ofp2 device along with a stratus insufflator.The fse informed the customer that per the user manual, a commercial tubing is not recommended due to a potential for poor flow, increased pressure and leaking.Related complaints: (b)(4).
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