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Model Number GIF-H190 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/16/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.The related complaints with patient identifier (b)(6) report the patient suspected with creutzfeldt-jakob disease (cjd).Numbers of patients that endoscopes were used on post suspected cjd risk: 1.Cf-hq190i / sn: (b)(6) was used on a total of 20 patients.The related complaints with patient identifiers are as follows: (b)(6).2.Gif-h190 sn (b)(6) was used on a total of 17 patients.The related complaints with patient identifiers are as follows: (b)(6).3.Pcf-h190dl sn: (b)(6) was not used on any other patients and was quarantined on site.
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Event Description
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It was reported, a total of three endoscopes, two colonovideoscopes and one gastrointestinal videoscope were used on a 72-year-old patient who is subsequently under investigation for suspected creutzfeldt-jakob disease (cjd).The equipment has been in use since the procedural date on 37 additional patients.The initial intended procedures were therapeutic, gastroscopy and colonoscopy, and were completed using the same set of equipment.The device was inspected before the initial use.At this time, no health hazards have been reported and there are no reports of any confirmed patient infections from the endoscopes.
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Manufacturer Narrative
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Correction to g3 of the initial report, the date received by the manufacture was feb 19, 2024.This report is being supplemented to provide additional information based on follow-up with the user facility and the legal manufacture's final investigation.Additional details were obtained by follow-up with the user facility where: the district health board (dhb) determined to destroy the subject device.The device is no longer in circulation.The user facility declined to provide any additional details to olympus, opting to communicate directly with medsafe.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the user was not aware of suspicion of cjd when they used the device to the patient.Accordingly, the device may have been used to other patients after reprocessing."precautions prions, which are the pathogenic agents of the creutzfeldt-jakob disease (cjd) cannot be destroyed or inactivated by the reprocessing methods stated in this instruction manual.When using the endoscope and accessories on patients with cjd or variant creutzfeldt-jakob disease (vcjd), be sure to use them for such patients only, or immediately dispose of them after use in an appropriate manner to prevent the usage of exposed devices on other patients.For methods to handle cjd, follow the respective guidelines in your country." olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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