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 has not been returned to omsc but was returned to olympus (b)(4).((b)(4)).The visual inspection of the subject device by (b)(4) confirmed following; there were chips and scratches on the adhesive of the bending section and the adhesives discolored to gray.There were dents and scratches on the distal end cover.There were wear and tear, brown parts, cracks and two pinholes on the adhesive of the distal end.The color of the adhesive was discolored to gray.There were cracks and missing part on the adhesive around the air/water nozzle, and the adhesives discolored to gray.There were cracks inside of the light guide lens.There were pinholes on the adhesive around the objective lens and light guide lens, and they were peeled off.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.Annual inspection was conducted on the subject device in (b)(6) 2017 and minor repair was conducted in (b)(6) 2017.The exact cause could not be determined at present, because the subject device is under the investigation.If significant additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during a routine surveillance culturing conducted by the user facility, the subject device tested positive for multi-drug resistance pseudomonas (1 cfu/ 100 ml).Olympus representative asked the hospital additional information, and obtained the following information.On (b)(6) 2018 the subject device used on a patient who was seen as the pseudomonas carrier.On (b)(6) 2018 the subject device was used on two patients.The user facility identified on one of two patients the same pseudomonas strain as on the carrier patient of (b)(6) 2018.The user facility reported that there was no special symptom with three patients.The user facility reported that the subject device had been reprocessed using soluscope 4, a non olympus automated endoscope reprocessor model.The forceps elevator was replaced in (b)(6) 2016 according to an olympus field corrective action.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation result and additional information from the user facility.A technical evaluation by olympus (b)(4) and a third party laboratory was carried out for the subject device.The primary evaluation report indicates the following; there was an air leak from the point between the distal end cover and the metallic part of the distal end.There was a dent on the distal end cover around the leak location.There was a lack of the glue at the leak point inside of the distal end cover.There was an oxidation inside of the distal end cover.There was a porous part in the o-ring.There were brown deposits.Olympus representative visited the user facility to obtain additional information and to assess the reprocessing practice at the user facility.The user facility informed olympus as follows; the two strains of psuedomonas aeruginosa were found from the infected patient (infected patient) who underwent ercp with the subject device on (b)(6) 2018 and one of two strains was the same strain as the patient (carrier) who was pseudomonas carrier and underwent ercp with the same device on (b)(6) 2018.After (b)(6) 2018, the subject device had been used for additional 4 patients but they had not been infected after the ercp.After the infection was found from the patient stated above, the subject device was removed from service.The infected patient had been in more difficult health condition than other patients before the ercp.On (b)(6) 2018, the user facility conducted microbiological testing for the subject device and the sample was tested (b)(6) for psuedomonas aeruginosa (1 cfu).The sampling of the subject device was performed by flushing sampling solution thorough the air/water channel and the suction channel, and swabbing the distal end.Same strain was found from the infected patient as that detected from the subject device.On the other hand, the strain was different from the one of the carrier.The user facility stated that the carrier and the infected patient had stayed in separate rooms.The history of the biological sampling for the subject device showed the result on (b)(6) 2017 and (b)(6) 2018 didn¿t clear the french guideline and the result on (b)(6) 2017 and (b)(6) 2017 cleared the guideline.The user facility stated that there was no change of their reprocessing practice recently.The user facility stated biological samplings of final rinse water from a non-olympus automated endoscope reprocessor (aer), soluscope serie 4, and water used for the aer had no problem.During the assessment of the reprocessing procedure at the user facility, following deviations from the instruction were observed.The user facility brushed the forceps elevator, channels, the adapter and the cylinders with a non-olympus brush.The user facility didn¿t flush the air/ water channel with detergent solution.The user facility did not rinse the endoscope prior to placement into the aer, but they use a cycle of the aer with a pre-rinse step to avoid manual rinsing.-after covering by a sterile drape, the subject scope has been stored in a horizontal position in the cabinet (cleanascope / surestore system).The exact cause could not be determined at present, because the subject device is under the investigation.If significant additional information is received, this report will be supplemented.

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 in the presence of olympus representatives.This report 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 revealed some deviations from what is considered to be the original manufacturing status as follows: - several dents and scratches on the distal end cover - glue peeled off at the rubber of the bending section level.Cracks on the glue close to the rubber of the bending section and the light guide lens.The laboratory commented that the presence of a white border indicates that the glue becomes porous.Lack of glue below the air/water nozzle.Presence of small cracks and brown residue around the objective lens and in the glue insuring the tightness between the distal end cover and the metallic part of the distal end.The presence of a white border indicates that the glue becomes porous.A leak detected at the distal end level due to a hole in the glue insuring the tightness between the distal end cover and the metallic part of the distal end.Lack of glue between the distal end cover and the internal hermetic casing (covering the forceps elevator arm) as the result of the surface sampling, contamination was detected following parts: on the external surface of the internal hermetic casing, more than 300 colonies of pseudomonas aeruginosa were found.On the internal surface of the distal end cover, where the leak was detected, more than 300 colonies of pseudomonas aeruginosa were isolated.On the internal area of the distal end, aspergillus brasiliensis and staphylococcus coagulase negative (total 2 cfu) were isolated.On the internal forceps axis inside the external forceps elevator, micrococcus spp (1 cfu) was isolated.On the internal forceps axis, staphylococcus coagulase negative (13 cfu) was isolated.Staphylococcus coagulase negative, micrococcus spp and bacillus spp (total 5 cfu) were isolated from the soil or oxidation residues on the internal hermetic casing.On the internal surface of the distal end cover below the elevator, staphylococcus coagulase negative (2 cfu) was isolated.The laboratory commented that the nature and number of microorganisms found on following sampling points; the internal area of the distal end, inside the external forceps elevator, the internal forceps elevator axis, the internal forceps axis and the soil or oxidation residues on the internal hermetic casing, indicates that these contaminations were more likely due to a contamination of the tests pieces by the environment or due to the manipulation of the test pieces during dismantling.Results of channel sampling indicate that after dismantling, 3 colonies (2 stenotrophomonas maltophilia and 1 micrococcus sp.) were isolated from the channels of the subject device.Sampling performed just after disassembling and after 48 hours of storage revealed only the presence of 24 colonies of burkholderia cepacia.Considering that these latest samples were performed in a non-controlled environment on a non-reprocessed endoscope, the presence thus contamination does not reveal a major contamination of the channels.Results of growth/no growth tests confirmed the presences of pseudomonas aeruginosa on internal hermetic casing and on the hermetic casing.The result also confirmed followings; no microbe on the forceps elevator screw and the external forceps.The presence of bacillus sp.On the internal forceps axis.The presences of acinetobacter calcoaceticus and bacillus sp.On the o-ring.The laboratory commented that the results for test piece of internal surface of the distal end cover seem to indicate that the hole in the glue insuring the tightness between the distal end cover and the metallic part of the distal end (that should have been detected if the leak test had been performed according to the instructions for use i.E.Performed in immersion) and the lack of glue between the distal end cover and the internal hermetic casing 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 endoscope and the distal end cover.The laboratory also reported that the fact that contaminated areas are not accessible to the reprocessing chemicals and procedure can explain the persistence/ growth of this contamination and the poor efficacy of the actual sampling method to detect this contamination.The exact cause could not be determined at present, because the subject device is under the investigation.If significant additional information is received, this report will be supplemented.

• 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: 7424492
• MDR Text Key: 105238307
• Report Number: 8010047-2018-00633
• 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,u
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2018

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
• Other Device ID Number: 04953170367311
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 04/16/2018; 06/18/2018
• Supplement Dates FDA Received: 05/11/2018; 07/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other