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Model Number FG-48L-1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 10/02/2009 |
Event Type
Injury
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Event Description
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Olympus reviewed the following literature titled "usefulness of a second endoscopic arm to improve therapeutic endoscopy in the lower gastrointestinal tract.Preliminary experience ¿ a case series".The aim of our study was to test the feasibility of utilizing a second endoscopic arm to exert counter-traction to lift the lesion away from the cutting plane, ameliorating submucosal exposure.Total eight patients were included in this study.Three complications occurred and were managed endoscopically.One patient experienced a small perforation in the sigmoid colon.Two patients presented with delayed bleeding.Applying counter-traction with a second endoscopic arm can facilitate submucosal dissection of distal colorectal lesions.Type of adverse events/number of patients.Perforation - 1 patient.Delayed bleeding - 2 patients.This literature article requires 9 reports.The related patient identifiers are as follows: (b)(6) for fg-48l-1, pt #4: perforation.(b)(6) for cf-q165i, pt #4: perforation.(b)(6) for fg-46u-1, pt #4: perforation.(b)(6) for fg-48l-1, pt #5: delayed bleeding.(b)(6) for cf-q165i, pt #5: delayed bleeding.(b)(6) for fg-46u-1, pt #5: delayed bleeding.(b)(6) for fg-48l-1, pt.#7: delayed bleeding.(b)(6) for cf-q165i, pt.#7: delayed bleeding.(b)(6) for fg-46u-1, pt.#7: delayed bleeding.This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.
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Manufacturer Narrative
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The authors report gf um160 was used to detect infiltration of the muscularis propria and/or the presence of perivisceral lymph nodes at preliminary endoscopic ultrasound which contraindicated endoscopic treatment and therefore excluded from the study.Xst-28ch-m is prototype device not cleared for market.The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
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Event Description
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The following additional information was received from the physician: ¿the adverse events described in the article are attributable neither to the olympus instrumentation nor to its malfunctioning, but rather to the method of submucosal dissection itself which, as is well known from the literature, is an invasive technique and subject to complications such as those described in the article.¿.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.This olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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