The subject device has not been returned to omsc for evaluation.As part of our investigation, the reprocessing practice of the user facility was checked, and there was no deviation.Omsc was informed that there were no fails or malfunctions on the subject device.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
|
This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) was informed that the serial number of the subject 4 devices are (b)(6).However, omsc was not informed that the information which device was used for which patient.The subject devices have not been returned to olympus medical systems corp.(omsc) but were returned to olympus key med.(okm).Okm sent the subject devices to a third party laboratory for microbiological testing after okm reprocessed the devices.As a result of the testing, following microbes were detected from the sample collected from the subject devices.[s/n:(b)(6)]: unspecified microbes (300cfu); [s/n:(b)(6)]: unspecified microbes (2100cfu); [s/n:(b)(6)]: unspecified microbes (370cfu); [s/n:(b)(6)]: unspecified microbes (400cfu).The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.This is 3 of 6 reports.
|
This supplemental report is being submitted to provide additional information and the subject device evaluation result.The all 4 devices have not been returned to olympus medical systems corp.(omsc) but were returned to olympus key med.(okm) for evaluation.Okm sent the devices to a third party laboratory for microbiological testing.As a result of multiple microbiological testing, following microbes were detected from the sample collected from the devices.August 9th, 2019 (after reprocessed by okm using an olympus automated endoscope reprocessor model etd-4 (not available in the usa)) [s/n:(b)(6) unspecified microbes (>100cfu from swab sample).[s/n:(b)(6) unspecified microbes (>100cfu from swab sample).[s/n:(b)(6) unspecified microbes (>100cfu from swab sample).[s/n:(b)(6) unspecified microbes (>100cfu from swab sample).September 19th, 2019 (after reprocessed by okm using an olympus automated endoscope reprocessor model etd-4 (not available in the usa) with low temperature steam formaldehyde (ltsf)) results reported in the follow up 1 mdr.September 26th, 2019 (after reprocessed by okm using an olympus automated endoscope reprocessor model etd-4 (not available in the usa) with ltsf) [s/n:(b)(6) unspecified microbes (>10,000cfu from water sample, and >6,000cfu from swab sample).[s/n:(b)(6) unspecified microbes (>10,000cfu from water sample, and >2,710cfu from swab sample).[s/n:(b)(6) unspecified microbes (>10,000cfu from water sample, and >6,000cfu from swab sample).[s/n:(b)(6) unspecified microbes (>10,000cfu from water sample, and >6,000cfu from swab sample).October 21th, 2019 no microbe was detected from the sample collected from the all 4 devices.The testing result cleared the german guideline.In addition, okm confirmed the followings in the evaluation.There were debris inside the distal end and a channel.There were cracks and scratches on the light guide lens.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.This is 3 of 6 reports.
|