Olympus medical systems corp(omsc) received a literature titled "does urgent balloon-assisted enteroscopy impact rebleeding and short-term mortality in overt obscure gastrointestinal bleeding?." background and aims: the diagnostic yield (dy) and therapeutic yield (ty) of balloon-assisted enteroscopy (bae) in overt obscure gastrointestinal bleeding (ogib) is higher in the first 72 h.This study aimed to evaluate if this higher dy and ty after urgent bae impacted the rebleeding rate, time to rebleed and short-term mortality.Methods: retrospective cohort-study, which consecutively included all patients submitted to bae for overt ogib, between 2010 and 2019.Patients were distributed in 2 groups: (1) urgent bae; (2) nonurgent bae.Rebleeding was defined as an hb drop >2 g/dl, need for transfusional support or presence of melena/hematochezia.Results: fifty-four patients were included, of which 17 (31.5%) were submitted to bae in the first 72 h.Dy and ty of urgent bae (dy 88.2%; n ¼ 15; ty 94.1%; n ¼ 16) was higher compared to non-urgent.Bae (dy 59.5%; n ¼ 22; ty 45.9%; n ¼ 17) (dy p ¼.03) (ty p ¼.001).The rebleeding rate at 1, 2, and 5 years was 32.0%, 34.0%and 37.0%, respectively.Rebleeding was lower after urgent bae (17.6%; n ¼ 3) compared to non-urgent bae (45.9%; n ¼ 17) (p ¼.04).Rebleeding tended to occurr earlier in non-urgent bae, being at 6-months (32.5%) and 36 months (41.3%) (p ¼.05).Ogib related 30-day mortality was 5.4% (n ¼ 2) for non-urgent bae and 0% for urgent bae (p ¼.5).Conclusion: urgent bae might be associated with higher dy and ty with lower rebleeding and trend toward higher rebleeding-free time. type of adverse events/number of patients.1) event 1: death(30-day mortality) -2 patient, 2) event 2: rebleeding -20 patients. this literature article requires 2 reports.The related patient identifiers are as follows: 1) (b)(6)/sif-q180/deaths.2) (b)(6)/sif-q180/rebleeding.The medwatch report is for patient identifier: olympus medical systems corp (omsc) received a literature titled "does urgent balloon-assisted enteroscopy impact rebleeding and short-term mortality in overt obscure gastrointestinal bleeding?." background and aims: the diagnostic yield (dy) and therapeutic yield (ty) of balloon-assisted enteroscopy (bae) in overt obscure gastrointestinal bleeding (ogib) is higher in the first 72 h.This study aimed to evaluate if this higher dy and ty after urgent bae impacted the rebleeding rate, time to rebleed and short-term mortality.Methods: retrospective cohort-study, which consecutively included all patients submitted to bae for overt ogib, between 2010 and 2019.Patients were distributed in 2 groups: (1) urgent bae; (2) nonurgent bae.Rebleeding was defined as an hb drop >2 g/dl, need for transfusional support or presence of melena/hematochezia.Results: fifty-four patients were included, of which 17 (31.5%) were submitted to bae in the first 72 h.Dy and ty of urgent bae (dy 88.2%; n ¼ 15; ty 94.1%; n ¼ 16) was higher compared to non-urgent.Bae (dy 59.5%; n ¼ 22; ty 45.9%; n ¼ 17) (dy p ¼.03) (ty p ¼.001).The rebleeding rate at 1, 2, and 5 years was 32.0%, 34.0%and 37.0%, respectively.Rebleeding was lower after urgent bae (17.6%; n ¼ 3) compared to non-urgent bae (45.9%; n ¼ 17) (p ¼.04).Rebleeding tended to occurr earlier in non-urgent bae, being at 6-months (32.5%) and 36 months (41.3%) (p ¼.05).Ogib related 30-day mortality was 5.4% (n ¼ 2) for non-urgent bae and 0% for urgent bae (p ¼.5).Conclusion: urgent bae might be associated with higher dy and ty with lower rebleeding and trend toward higher rebleeding-free time. type of adverse events/number of patients.1) event 1: death (30-day mortality) -2 patients.2) event 2: rebleeding -20 patients. this literature article requires 2 reports.The related patient identifiers are as follows: 1) (b)(6)/sif-q180/deaths.2) (b)(6)/sif-q180/rebleeding.The 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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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 supplemental report includes additional information provided by the author.Olympus will continue to monitor field performance for this device.
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