Model Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Abscess (1690)
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Event Type
Injury
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Manufacturer Narrative
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The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the lot number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices which passed the inspection.Based on the reported event, it is presumed that the reported complications were not due to the malfunction of the device, but occurred as a general complications of the procedure.
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Event Description
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On november 25, 2019, olympus medical systems corp.(omsc) received a literature titled ¿push vs pull method for endoscopic ultrasound-guided fine-needle aspiration of pancreatic head lesions: propensity score matching analysis.¿ the literature reported the result of 201 cases (push group: the ratio of male-to-female was 48:37.The mean age of the patients was 67.1 years.Pull group: the ratio of male-to-female was 46:39.The mean age of the patients was 67.6 years.) of the endoscopic ultrasound-guided fine-needle aspiration (eus-fna) of pancreatic head cancer from february 2001 to december 2017.In the literature, it was reported that olympus ultrasonic gastrovideoscope (gfy0005-uct, gf-uc240p-al5, gf-uct240-al5, and/or gf-uct260), olympus endoscopic ultrasound center (eu-me1 and/or eu-me2), and/or olympus aspiration needle (na-200h-8022, na-220h-8022, na-u200h-8022, and na-11j-kb) might be used.In the subject cases, 1 case of abscess around pancreas occurred.Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined.This is the report regarding abscess around pancreas with the subject device.
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Manufacturer Narrative
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Based on the information in the literature, only the device series name was reported, and the specific model number was not reported.Therefore, ez shot 22g (na-200h series), ez shot 2 22g (na-220h series, na-230h series), ez shot 3 plus 22g (na-u200h series), and/or na-11j-kb might be used in the subject cases.
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Search Alerts/Recalls
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