Model Number SIF-Q180 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Type
Injury
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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.A review of the instrument¿s history could not be performed.Furthermore, it was stated by the study's physician that although the patient developed an air leak, "this is a known risk of peg insertion and occurred despite good landmarking." device will not be returned.
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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 in 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 study patient had the peg tube placed but developed an air leak around the peg after insertion.The patient was subsequently taken back to the operating room where an aberrant loop of mesentery was found between the abdominal and anterior gastric wall preventing apposition to form the gastrostomy tract.The pegj device was removed, and re-inserted after the mesentery had been relocated, and the patient recovered fully.This report is for patient 1 of 2 for subject study.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.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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