MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II DUODENOVIDEOSCOPE

Model Number TJF-Q180V

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 07/18/2017

Event Type  Death  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.An inspection was conducted by an olympus staff at the facility.The subject device passed the leakage testing and there was no abnormality noted and no debris observed in its appearance, the distal tip and biopsy channel.Omsc reviewed the manufacture history of the subject device and confirmed the subject device was manufactured after design change of the forceps elevator and there was no irregularity in the history.The subject device was returned to ofr for elevator mechanism breakage on december 5, 2016 and sent back to the facility after repair.The exact cause could not be determined at present, olympus is planning to follow up with the facility to assess the detailed reprocessing procedure and evaluate the subject device.If significant additional information is received, this report will be supplemented.

Event Description

Olympus (b)(4) was informed that five patients tested positive for pseudomonas aeruginosa after having undergone endoscopic retrograde cholangiography (ercp) using the subject device since (b)(6) 2017 at the facility.During the initial phase of these events, the test result of the microbiological testing at the facility on (b)(6) 2017 cleared the french guideline and the facility did not inform ofr of the two patient infections in the beginning of may.A third patient was reported to be contaminated at the end of june and the facility believed the contamination due to the patient itself.The fourth and fifth patients were reported to be contaminated on (b)(6).The facility reported that four patients are doing well except for one patient who was hospitalized with fever.The first microbiological testing for the subject device on (b)(6) was reportedly conducted while the forceps elevator was in a lowered position and the subject device tested positive for unspecified microorganism(1/cfu/190 ml) but the test result cleared the french guideline.Additional microbiological testing was conducted in july for the subject device while the forceps elevator was in an upper position and the subject device tested positive for pseudomonas aeruginosa (>100 cfu/190 ml).The subject device was cleaned with olympus brushes (model:bw-412t, maj-1888) and was reprocessed using a non-olympus automated endoscope reprocessor (aer:brandname:wassenburg, model:adapterscope) with peracetic acid.The microbiological testing for the rinsing water of the aer was negative for pseudomonas aeruginosa but some of the test result did not clear the french guideline due to unspecified microbial growth.This is one of five reports.

Manufacturer Narrative

The subject device was sent to a third party laboratory and it is under evaluation supported by olympus.On (b)(6) 2017, olympus received updated interim evaluation report from the laboratory.This supplemental report is being submitted to provide the updated interim evaluation result of the subject device.At the laboratory, technical inspection of the endoscope was conducted before disassembling of the distal end portion.The inspection did not reveal any functional problems or leak but the visual inspection of the distal end revealed some deviation from original manufacturing condition as following.Discoloration and presence of cracks at the adhesive on bending section rubber.Absence of adhesive between the lens cover and the distal tip cover.Absence of adhesive around the air/water nozzle.Absence of glue on the top of the screw connected to the proximal part of the forceps elevator.After the disassembling, a test to detect amino acids and protein on the deposits found at the screw was negative but complementary tests are in progress to try to identify the exact nature of the deposit (organic or inorganic).The microbiological testing for the biopsy channel indicated the presence of (b)(4) colonies of pseudomonas aeruginosa where the sampling was performed just after the disassembling.The sampling from the biopsy channel and air water channel performed after 24 hours of incubation at room temperature revealed the presence of (b)(4) colonies (the biopsy/suction channel; 27cfu, the air/water channel: 27cfu) of coagulase (b)(6) (human contamination) but the absence of pseudomonas aeruginosa.Olympus is evaluating the subject device at a third party laboratory continuously.If significant additional information is received, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus representative visited the facility to obtain additional information and to assess the reprocessing practice at the user facility.The facility informed that, all of the five patients suffered from disorders of the bile tract (obstruction due to tumor) before the ercp procedure and the bile duct could not drain naturally.The ercp procedures were reportedly complicated and it took longer time than average ercp procedure.The five patients needed antibiotic treatments after the procedure.Four of five patients are in improved condition except for one patient who deceased as a consequence of his medical history.The facility reported the decease had no association with the infection.The facility reported that they possesses three tjf-q180v (including subject device: serial number (b)(4)) and only the subject device was linked to the infections.The other tjf-q180v had no issue of infection and the microbiological culturing tests by the facility indicated no microbial growth for them while the test conducted with the forceps elevator in intermediate position.The facility said there have been no changes in the reprocessing procedure, the personal in charge of reprocessing and chemicals such as detergent solution used for the reprocessing.During the assessment of the reprocessing procedure at the facility, olympus noted that the facility did not use air/water channel adapter mh-978 for bedside cleaning.They did not use olympus leakage tester mu-1 but non-olympus handy leakage tester (model name; unknown).The pressure setting of the tester was 200-240mmhg and the setting was lower than the mu-1.The buck of the elevator channel was not brushed with olympus brush bw-412t when the forceps elevator was raised.The distal end was not immersed into detergent solution during the brushing of the forceps elevator with olympus brush maj-1888 and the forceps elevator was not intentionally raised and lowered while immersing into detergent solution.The hole of the air/water valve of endoscopes was not brushed and was not flushed with detergent solution.The user facility staff handle endoscopes with bare hand that was disinfected by the alcohol based hand disinfectant during drying of the endoscope.The exact cause could not be determined at present.Olympus is evaluating the subject device at a third party laboratory.If significant additional information is received, this report will be supplemented.

Manufacturer Narrative

The subject device was sent to a third party laboratory and it is under evaluation supported by olympus.On (b)(6) 2017, olympus received an interim evaluation report from the laboratory.On october 27, olympus representative visited to the user facility to obtain on further information on reprocessing method and storage condition of the subject device.This supplemental report is being submitted to provide the interim evaluation result and additional information from the facility.At the laboratory, microbiological culturing test and appearance evaluations for the subject device were conducted after disassembling the distal end portion.In the culturing test and evaluation, some parts tested positive for pseudomonas aeruginosa (p.A.) and brown deposit were observed as following.The forceps elevator recces (the internal surface of the distal end): a part of the recess tested positive for p.A.(6cfu).Moisture was detected in side wall of the recess.O-ring connected to the forceps elevator arm: no microbial growth but brown deposit found.Screw connected to the proximal part of the forceps elevator: no microbial growth but brown deposit found.External surface of the forceps elevator: tested positive for p.A.(21cfu).Internal surface of the distal end plastic cover: tested positive for p.A.(>300cfu).Biopsy channel: tested positive for p.A.(>26 cfu).The test for other parts including internal forceps elevator axis indicated no microbial growth and no irregularity at present.Olympus representative visited the facility on (b)(4) to obtain further information on the biological sampling of the tjf-q180v conducted at the facility on (b)(6) which detected pseudomonas aeruginosa later.The facility reported that before the sampling, the subject device was manually cleaned and reprocessed using non olympus automated endoscope reprocessor (aer: adapterscope) on (b)(6).After the reprocessing, it was dried manually for 5 minutes and covered with sterile drape for approximately 6 hours.Afterwards, the subject device was put in the aer followed by manual drying.Then the subject device was stored in a scope carrying case instead of a drying cabinet until it was sent to the laboratory for the evaluation.The case was reportedly disinfected with a disinfectant liquid spray before the storage.The setting in the each reprocessing process of the aer is as below.Process : time :temperature (degree).Leakage test : 59 sec : no information.Pre rinsing : 20 sec : no information.Cleaning : 5 min 10 sec : no information.Rinsing : 20 sec : no information.Second cleaning : 5 min 09 sec : 37.Rinsing : 20 sec : 30.Disinfection : 10 min 09 sec : 31.Rinsing : 1 min : 22.Final rinsing : 1 min : 22.Leakage test : 59 sec : no information.Olympus is evaluating the subject device at a third party laboratory continuously.If significant additional information is received, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide the additional information of the pseudomonas aeruginosa (p.Aeruginosa) that were detected in the patients and the subject device.At the user facility, the strains (number of sample: 5) of the p.Aeruginosa from the three infected patients were compared with the strains (number of sample: 5) from the subject device using polymerase chain reaction (pcr) test.The test confirmed all strains had identical profiles and the user facility concluded that all pseudomonas had same strain.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information on the evaluation report of the subject device.Olympus received a final evaluation report on the subject device by a third party laboratory on (b)(6) 2018.Although, all content of the report have been reported in former medical device report mdr (initial, follow up #1, follow up #2, follow up #3 and follow up #4), the final evaluation report is attached to this mdr for your reference.(b)(4).

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 6812711
• MDR Text Key: 83484960
• Report Number: 8010047-2017-01230
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Other Device ID Number: 04953170367311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 08/23/2017
• Supplement Dates Manufacturer Received: 09/19/2017; 10/10/2017; 11/02/2017; 04/12/2018; 05/14/2018
• Supplement Dates FDA Received: 10/17/2017; 11/07/2017; 11/28/2017; 05/10/2018; 06/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/19/2016
• 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): Death; Other