Model Number UCR |
Device Problem
Improper Flow or Infusion (2954)
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Patient Problem
Injury (2348)
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Event Date 12/18/2018 |
Event Type
Injury
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Manufacturer Narrative
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The device hat not yet returned to olympus for evaluation.The exact cause of the reported event could not be determined at this time.The instruction manual for the ucr warns ¿during use, always stop the device and light source from supplying air.If stop is not selected, a mixture of air and co2 may be supplied into the patient body.In addition, the instruction manual for the clv-190 (section 5.9) light source that is used with the ucr also provides warning that states ¿over-insufflating the lumen may cause patient pain, injury, bleeding, gas embolism, and/or perforation.¿.
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Event Description
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Olympus was informed that during a colonoscopy, while introducing the endoscope towards the caecum, the surgeon visualized the presence of hematomas and stripes on the walls on the intestine, prompting the surgeon to immediately abort the procedure and withdraw the endoscope.The patient was sent to the radiology department for a ct scan which showed "free air" in the patient's intestine.The customer claimed that the device reported expelled too much co2 into the patient.The patient was however discharged and sent home.The same night of the event, the patient was presented to the emergency room with persisting abdominal pain.A second ct scan was performed, which still showed ¿¿free air¿¿, but not requiring surgery.The patient was admitted and treated with antibiotics.
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Manufacturer Narrative
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This supplemental report is being submitted to make a correction on the procode from het to hif.
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Manufacturer Narrative
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The device was returned to olympus for evaluation.A visual inspection was performed on the returned device and found a small dent on the rear corner of the top cover and a missing screw.The internal parts were found to be in good condition and intact.The device was connected to the test co2 gas cylinder via a regulator.The device passed all the implemented inspection items, and the measurable inspection results are within the specification.Based on the evaluation findings, the reported complaint was not confirmed.The device passed all functional inspection and works as designed.Additionally, the original equipment manufacturer (oem) performed a review of the investigation findings and reported that a root cause could not be determined as the device functioned as intended.The oem performed a review of the dhr for the device model/serial number and found no abnormalities during the manufacturing of this device.In effort to mitigate patient injury the oem referenced the following ifu statements: when the endoscopic co2 regulation unit is used to examine a patient, do not allow metal parts of the endoscope or its accessories to touch metal parts of other system components.Such contact may cause unintended current flow to the patient.If the insufflator emits a caution (caution light or alarm) for cavity over-pressurization, quickly open the stopcock or valve of the trocar.Then, reduce the amount of outflow from the laser device, argon-enhanced coagulator, or other gas supply device.If use is continued while the alarm sounds, there is a risk of gas embolism due to cavity over-pressurization.Be careful not to feed co2 too much during co2 gas feed or spraying.Excessive co2 gas feed/spraying may cause pain to the patient and/or gas embolism.Reduce the use of co2 gas feed and spraying at the requisite minimum level.In case the insufflator is used in operation, open the trocar cannula stopcock if the pressure in the abdomen exceeds the set pressure by more than 5 mmhg.Do not attempt to insufflate the abdominal cavity using the lens cleaning sheath.Otherwise, patient injury and/or gas embolism may result.Do not use the endoscopic co2 regulation unit in combination with other than the compatible lens cleaning sheath (with the maj-1345, maj-1537, or maj-659, for example).Otherwise, co2 gas is fed continuously and patient pain and gas embolism can result.
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Search Alerts/Recalls
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