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

Model Number TJF-Q180V

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The subject device in this report has not yet been returned to olympus medical systems corp.For evaluation.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 (b)(4) for elevator mechanism breakage on (b)(6) 2016 and sent back to the facility after repair.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 three patients developed unspecified complications during bile drainage of ercp.It is also fact that the subject device was used about 10 patients during those examined, but all of them were not infected and didn't develop any complications.The user facility conducted three times of microbial culture test for the subject device after the patient infection.The results of three tests are as follows.[first time: (b)(6) 2018] no microbe was detected from samples taken from the all channels of the subject device.[second time: (b)(6) 2018] the all channels: klebsiella pneumoniae, e.Coli and e.Coli blse (>200 cfu/100 ml).[third time: (b)(6) 2018] the air/water channel: unspecified microbes (1 cfu / 100 ml); the instrument channel: unspecified microbes (12 cfu / 100 ml).During three times of microbial culture test, there was no detection of the infection relevant pseudomonas aeruginosa carbapenem.During the assessment of the reprocessing procedure at the facility, olympus noted that deviations were observed during brushing of the subject scope using maj-1888.When olympus found deviations, they were shared with the user facility.The exact cause could not be determined at present.If significant additional information is received, this report will be supplemented.

Event Description

Omsc was informed that two patients acquired infection after ercp procedures, on different dates, with the subject device.Patient one's abdominal fluid tested positive for pseudomonas aeruginosa carapenem after an ercp procedure on (b)(6) 2018.Patient two's blood tested positive for pseudomonas aeruginosa carapenem after an ercp procedure on (b)(6)2018.The other patient was known to be infected pseudomonas aeruginosa carapenem prior to (b)(6) when the patient undergoes ercp.Physical conditions of all three patients were getting better now.The user facility reported that the subject device had been reprocessed using wassenburg, a non-olympus automated endoscope reprocessor model using peracetic acid.This report is 1 of 2 reports.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation result.The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus (b)(4).The subject device was sent to a third party laboratory and the laboratory carried out technical investigation.The following description refers to the enclosed laboratory¿s report; at the laboratory, technical inspection of the subject device was conducted before disassembling of the distal end portion.The inspection did not reveal any functional problem or air leakage but the visual inspection of the distal end revealed deviations from original manufacturing condition as following; there was the hole in the glue insuring the tightness between the distal end cover and the metallic part of the distal end.In addition, the visual inspection confirmed that the index of length of the insertion tube became porous.After the disassembling, the following was observed.There were brown deposits on the internal surface of the distal end cover.This brown deposit was later identified as a residue of silicone used to seal the external sheath on the metallic part of the distal end.There was moisture located between the internal surface of the distal end cover and the metallic part of the distal end.The microbiological testing for the surface of the subject device was conducted and the test results were as follow; on the area located between the external forceps elevator and the distal end of the subject device where 1 colony of klebsiella pneumoniae and 2 colonies of bacillus sp.Were isolated.On the internal surface of the shaft hole for the forceps elevator where 16 colonies of klebsiella oxytoca, 6 colonies of citrobacter spp., 2 colonies of pseudomonas aeruginosa and 1 colony of staphylocoque coagulase negative were isolated.2 colonies of citrobacter spp.Were also isolated on the internal forceps elevator axis inside the external forceps elevator.On the internal surface of the distal end cover where more than 300 colonies of pseudomonas aeruginosa and klebsiella oxytoca were isolated.On the surface of the internal distal end cover where 1 colony of bacillus was found.The laboratory commented that considering the nature and the number of microorganisms isolated, this contamination is more probably due to a contamination of the sample during sampling.After the disassembling the subject device, the microbiological testing for the channels of the subject device was also conducted and the test results and the comment of the laboratory were following; results of channel sampling indicated that channels of the subject device were not contaminated.Considering that the results of the sampling performed after 24 hours of storage in a non-controlled environment did not reveal any contamination, the presence of 5 colonies of coagulase negative staphylococci (human contamination) in the air water channel just after dismantling was probably due to a contamination of the sample during sampling.Results of growth/no growth tests confirm the presence of klebsiella oxytoca and citrobacter spp.On the distal end cover and show also that these microorganisms are present on the internal distal end cover and the external forceps elevator.Staphylocoque coagulase negative was isolated on the forceps screw.Micrococcus spp.Was isolated on the o-ring.The results for the test piece (sampling from the internal surface of the distal end cover) seem to indicate that the hole in the glue between the distal end cover and the metallic part of the distal end may have led to the accumulation of water and the contamination of some areas located between the metallic parts constituting the distal end of the subject device and the distal end cover.The exact cause of the reported phenomenon could not be conclusively determined.If additional information becomes available, this report will be supplemented.This report is 1 of 2 reports.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation result.Olympus received a strains analysis report by the user facility on (b)(4) 2018.Olympus also received a final evaluation report with the strains analysis results and the third party laboratory's comments updated by a third party laboratory on (b)(4) 2018.Characterization tests performed by ribotyping indicate that klebsiella pneumoniae isolates were different, one of which was found in endoscope channels in the user facility and another was found in the internal area of the distal end.On the other hand, these results confirm that five strains of the pseudomonas aeruginosa were the same: strains isolated on each of three patients, the internal forceps elevator axis inside the external forceps elevator, and the internal surface of the distal hood on the endoscope.These strains of pseudomonas aeruginosa were identified by the user facility as vim-2 metallo-beta-lactamase, per-1 beta-lactamase and oxa-4 oxacillinase producing strain.In addition, the third party laboratory commented about the biological result of the internal forceps axis as follows; the growth observed in sampling point ¿the internal surface of the shaft hole for the forceps¿ but no contamination was observed on sampling three points: ¿area between the external sheet and the hermetic casing¿, ¿internal forceps axis inside the external forceps¿ and ¿o-ring¿.These results indicate that this contamination is more related to the contamination observed on sampling point ¿internal surface of the distal hood¿ or may even result from the dismantling process rather than to a possible fluid ingress via the o-ring or the internal forceps, as these sampling areas do not show any microbial growth.This section refers to the enclosed laboratory¿s report.The exact cause of the reported phenomenon could not be conclusively determined.This report is 1 of 2 reports.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7340578
• MDR Text Key: 102444807
• Report Number: 8010047-2018-00442
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• PMA/PMN Number: PK143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 03/27/2018; 05/16/2018
• Supplement Dates FDA Received: 04/25/2018; 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other