[115670844]
This report was received from a healthcare professional (administrator) on 02-jul-2018. This case describes the occurrence of retroperitoneal perforation in a (b)(6) year-old outpatient female who underwent a virtual colonoscopy with colon insufflator protocol on (b)(6) 2018 for screening of polyps and cancer. Medical history and concomitant medications were reported as none. The patient had no known allergies. On (b)(6) 2018, the patient underwent a virtual colonoscopy with colon insufflator protocol (catalog number 6400, serial number (b)(4)). The patient tolerated the colonoscopy procedure without complications and was sent home. Approximately an hour after the patient left, the images were read. The images showed the patient as having retroperitoneal perforation; co2 was present. Although the patient was asymptomatic, the patient was immediately called into the emergency room and was admitted for a "couple of days" and was discharged home sometime in (b)(6) 2018. Treatments given and outcome were not provided. On (b)(6) 2018, preliminary investigation showed all mechanical and electronic pressure relief valves functioned as expected. The unit was tested for proper operation and did not perform as expected. The flow calibration was out of spec. The flow meter reads 5. 3 l/min and volume liter display reads 5. 6 l/min. Additional information is required pending final results of quality investigation. Corresponding worldwide case id: (b)(4). Company comment: a (b)(6) year-old outpatient underwent a virtual colonoscopy with colon insufflator protocol for screening of polyps and cancer. She tolerated the procedure and was sent home. After an hour, they read the images and showed retroperitoneal perforation with co2. Although the patient was asymptomatic, they called her immediately and admitted her for a "couple of days". Treatment was not reported. During preliminary investigation of the unit, all mechanical and electronic pressure relief valves functioned. However, the flow calibration was out of spec. The flow meter reads 5. 3 l/min and volume liter display reads 5. 6 l/min. Colon perforation is a rare but serious complication of colonoscopy and may occur as either intraperitoneal or extraperitoneal perforation or in combination. In this specific case, no information is available regarding the underlying conditions of this elderly patient suspected to suffer from polyps and cancer. In the meantime, no information was provided regarding the course and outcome of the examination, together with final results of quality investigation. Due to the lack of critical information, this case is considered unassessable. Further evaluation will be performed once additional information is received.
Patient Sequence No: 1, Text Type: D, B5