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Model Number KD-611L |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Perforation (2001)
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Event Date 10/26/2023 |
Event Type
Injury
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Manufacturer Narrative
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This report is related to the following linked patient identifiers: (b)(4).The device was not returned.Attempts were performed to obtain additional information, but no response was received.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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Olympus reviewed the following literature titled "untutored training pathway to achieve competence in esophagogastric endoscopic submucosal dissection in a western center." the aim of this study was to assess the efficacy of an endoscopic submucosal dissection (esd) unsupervised training model for experienced endoscopists.Stepwise training included a visit to a high-volume center, unsupervised training on an ex vivo porcine model, and in vivo human upper gastrointestinal cases with anatomic progression.Performance measures included en bloc resection, r0 resection, adverse event rates, and operating time.Circumferential incision was performed with a dualknife (kd-650q or kd-650l) and dissection was performed with a dualknife or itknife (kd-611l or kd-612).Perforation gastric: 5 patients total 2 cases were converted to laparoscopic sleeve gastrectomy due to perforation.1 case required total gastrectomy due to severe submucosal fibrosis.2 gastric cases were converted to surgery.Esophageal: 3 patients total all managed with clips bleeding gastric: 1 patient requiring hospitalization.Esophageal: 1 patient requiring hospitalization.
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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, a 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 supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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