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

Model Number CYF-VA2

Device Problems Device Reprocessing Problem (1091); Contamination /Decontamination Problem (2895); Device Contamination With Biological Material (2908); Device Contamination with Chemical or Other Material (2944)

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Date 08/30/2016

Event Type  Injury  

Manufacturer Narrative

The devices referenced in this report were returned to olympus for evaluation.Evaluation for the 1 of 2 devices numbered (b)(4): according to the evaluation, there were brown deposits in the connector ring of t-plug, at an opening of the biopsy channel, around the objective lens, and on the covering of bending section.There was a scratch at the place of around 60mm from the distal end inside the biopsy channel.For the biopsy channel, there was buckling at the place of around 105mm, 150mm, and 200mm from the distal end.There were no other remarkable scratches and deposits found on the outer appearance, and inside the channel.This device was manufactured on april 8, 2014.The manufacturing record of the subject device was reviewed without irregularity related to this event.After the subject device was shipped on june 3, 2014, there were no repair records by olympus.Evaluation for the 2 of 2 devices numbered (b)(4): according to the evaluation, there were brown deposits in the connector ring of t-plug, at an opening of the biopsy channel, around the objective lens, and on the covering of bending section.There was a scratch at the place of around 60mm from the distal end inside the biopsy channel.For the biopsy channel, there was buckling at the place of around 105mm from the distal end.There were no other remarkable scratches and deposits found on the outer appearance, and inside the channel.This device was manufactured on june 8, 2006.The manufacturing record of the subject device was reviewed without irregularity related to this event.After the subject device was repaired on august 19, 2014, there were no repair records by olympus.Based on upon the evaluation, the following possibility could not be ruled out as a contributory factor of the event: the patient was infected because the user facility did not conduct the cleaning in accordance with the ifu of the subject device, which caused insufficient re-processing.Please cross reference the following mdr report numbers#: 8010047-2016-01229, 8010047-2016-01231 and 8010047-2016-01232.

Event Description

Four patients were infected with pseudomonas aeruginosa after undergoing a cystoscopy procedure.The first patient: the patient underwent a cystoscopy procedure on (b)(6) 2016.The patient had a symptom of fever from (b)(6) 2016, so revisited the hospital.Since pseudomonas aeruginosa was detected from urine, the patient was hospitalized for examination, and antibiotics were administered.The symptom is currently improving.The second patient: the patient underwent a cystoscopy procedure on (b)(6) 2016.After that, physical condition became worse, so the patient revisited the hospital.Pseudomonas aeruginosa was detected from urine.The patient was diagnosed as epididymitis, and antibiotics were administered.The patient returned home after receiving only outpatient treatment, and the symptom is currently improving.The third patient: the patient underwent a cystoscopy procedure on (b)(6) 2016.On the same day, pseudomonas aeruginosa was detected from urine.The patient was diagnosed as cystitis, and antibiotics were administered.The patient returned home after receiving only outpatient treatment, and the symptom is currently improving.The fourth patient: the patient underwent a cystoscopy procedure on (b)(6) 2016.On the following day, the patient had a symptom of urinary retention, so revisited the hospital.Pseudomonas aeruginosa was detected from urine, and antibiotics were administered.The patient returned home after receiving only outpatient treatment, and the symptom is currently improving.On (b)(6) 2016, as a result of conducting a culture test of the subject device and another cyf-va2, pseudomonas aeruginosa was detected from both of the devices.It is unknown which device was used on the four patients.The doctor in charge commented that "when only observation was carried out, the brushing of the biopsy channel was not conducted.There is room for improvement in handling of the scope".Olympus customer service confirmed that the user facility did not conduct the cleaning in accordance with the ifu of the subject device, and dirt adhered to the covering of bending section.On cleaning, the user facility did not use the channel-opening cleaning brush (mh-507).Further, after using devices on saturday and sunday, the devices were left unattended for a long time.No bacteria were detected from the dirt part of the covering of bending section and the outer surface of the subject device.

Manufacturer Narrative

This supplement report is submitted to report additional information.Evaluation for the 1 of 2 devices numbered: (b)(4): there were brown deposits in the connector ring of t-plug, at an opening of the biopsy channel, around the objective lens, and on the covering of bending section, so components of the deposits were analyzed.For the brown deposits in the connector ring of t-plug, as a result of analysis, they were a compound of sus rust and an inorganic substance (silicic acids, phosphoric acids).From the analysis result, it may be rusted by tap water, chemicals, etc.For the brown deposits at an opening of the biopsy channel, as a result of analysis, they were a compound of sus rust and silicic acids.From the analysis result, it may be rusted by tap water, chemicals, etc.For the brown deposits around the objective lens, as a result of analysis, they were a compound of protein, silicic acids, and sodium chloride.From the analysis result, it may be originated from humans, bacteria, protein-based chemicals, tap water, chemicals, a physiological saline, etc.For the brown deposits on the surface of the covering of bending section, as a result of analysis, they were protein.From the analysis result, it may be originated from humans, bacteria, protein-based chemicals, etc.Olympus repair department inspected the subject device, and it was determined there was a need for repair because the angle operability, dirt at an opening of the biopsy, external appearance of the insertion tube and the distal end, accessories, the brush insertability, and water leak did not satisfy the repair standards.Evaluation for the 2 of 2 devices numbered: (b)(4): there were brown deposits in the connector ring of t-plug, at an opening of the biopsy channel, around the objective lens, and on the covering of bending section.In addition, there were white deposits on suction cylinder, so components of the deposits were analyzed.For the brown deposits in the connector ring of t-plug, as a result of analysis, they were a compound of sus rust and an inorganic substance (silicic acids, phosphoric acids).From the analysis result, it may be rusted by tap water, chemicals, etc.For the brown deposits at an opening of the biopsy channel, as a result of analysis, they were a compound of sus rust and silicic acids.From the analysis result, it may be rusted by tap water, chemicals, etc.For the brown deposits around the objective lens, as a result of analysis, they were a compound of protein, silicic acids, and sodium chloride.From the analysis result, it may be originated from humans, bacteria, protein-based chemicals, tap water, chemicals, a physiological saline, etc.For the brown deposits on the surface of the covering of bending section, as a result of analysis, they were protein.From the analysis result, it may be originated from humans, bacteria, protein-based chemicals, etc.For the white deposits on suction cylinder, as a result of analysis, they were sodium chloride.It may be originated from chemicals, a physiological saline, etc.Olympus repair department inspected the subject device, and it was determined there was a need for repair because the angle operability, dirt at an opening of the biopsy, external appearance of the insertion tube and the distal end, and water leak did not satisfy the repair standards.The possible cause of this event is not changed from the initial report.Please cross-reference to mdr#: 8010047-2016-01229, 8010047-2016-01231 and 8010047-2016-01232.

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 6425177
• MDR Report Key: 5986254
• MDR Text Key: 55875247
• Report Number: 8010047-2016-01230
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K#: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CYF-VA2
• Device Catalogue Number: CYF-VA2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other