MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Sepsis (2067)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Olympus medical systems corp.(omsc) was informed that 6 patients have experienced symptoms like inflammation and sepsis after procedures using the subject device.The date of the 6 procedures and the patients outcome attributed to the event are as follows; patient 1 underwent a procedure on (b)(6) 2018; urine specimen tested positive for enterococcus faecalis.Patient 2 underwent a procedure on (b)(6) 2019; no specimen test was conducted.Patient 3 underwent a procedure on (b)(6) 2019; blood cultures and urine specimen tested negative.Patient 4 underwent a procedure on (b)(6) 2019; blood cultures and urine specimen tested negative.Patient 5 underwent a procedure on (b)(6) 2019; blood cultures and urine specimen tested negative.Patient 6 underwent a procedure on (b)(6) 2019; blood cultures and urine specimen tested negative.No microbe was detected from the sample collected from the subject device as a result of microbiological testing by the user facility.The patients were given additional treatment and became stable.This is 5 of 6 reports.

Manufacturer Narrative

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 5 of 6 reports.

Manufacturer Narrative

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.On (b)(6) 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).On (b)(6) 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.On (b)(6) 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).On (b)(6) 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 5 of 6 reports.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8943730
• MDR Text Key: 160879087
• Report Number: 8010047-2019-03122
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-VH
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other