Model Number SIF-Q180 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Death (1802)
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Event Type
Death
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Manufacturer Narrative
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The article did not specify the serial number of the referenced scope; therefore, it is unknown if the scope was returned for repair/service.An instrument history is unable to be performed.Furthermore, the study's physician provided a probable cause of the reported death stating that "it was hypothesized that the patient's death may have been due to air embolism, although a pulmonary embolism, mucus plug, arrhythmia, and myocardial infarction are also possibilities.Prolonged manipulation and endoscopy time may result in more leakage of air through a newly formed gastrostomy into the peritoneum.However, the jejunal extension insertion using a single-balloon enteroscope is actually faster than the standard technique because of the lack of retrograde migration, and thus it was felt that this did not contribute to the adverse outcome in this patient.".
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Event Description
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Olympus received an article titled ¿insertion of percutaneous endoscopic gastrostomy tubes with jejunal extensions using the ¿wedge¿ technique: a novel method to prevent retrograde tube migration into the stomach¿.There were 17 patients on the study.The article reported that two adverse events occurred due to peg insertion although none were related to the jejunal extension insertion itself using the wedge technique.One female patient developed asymptomatic pneumoperitoneum after the procedure.She was discharged 6 hours later when a repeat abdominal x-ray showed resolution of most of the free air.She remained asymptomatic until noon the following day when she took a nap with her husband, coughed once, and stopped breathing.Resuscitation was not performed, following the patient¿s prior wishes.An autopsy was offered but declined.This is patient 2 of 2 adverse events for the subject study.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.Please see the updates in sections: g4, g7, h2, h6 and h10.The legal manufacturer reviewed the contents of this complaint.The exact root cause of the reported event could not be determined.As there was no reported malfunction of the subject device related to the events.In addition, there was no proof/description to show the association between the adverse events and the subject device.
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Search Alerts/Recalls
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