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

Model Number TJF-Q180V

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

Patient Problem Unspecified Infection (1930)

Event Date 04/23/2019

Event Type  Injury  

Manufacturer Narrative

Olympus (b)(4) reviewed the service history for the subject device.The subject device was returned to (b)(4) on july 10th, 2018 for the most recent repair and there was no repair required.On june 11th, 2019, a representative of olympus (b)(4) visited the user facility to review the reprocessing process at the user facility.There was no dirt on and around the forceps elevator of their tjf-q180v.In addition, there were no deviations of reprocessing practice noted at the user facility.The subject device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that total three patients were infected with pseudomonas aeruginosa after duodenoscopies using the subject device between april 26th, 2019 and may 16th, 2019.It was also reported that the three patients developed septicemia, suspected nosocomial.The three patients were colonized pseudomonas aeruginosa.Those strains isolated in the patients were identical.The user facility had cleaned the subject device using an olympus single use cleaning brush (bw-412t) with a non-olympus detergent (anios clean excel d), and an olympus single-use brush (maj-1888) was also well used.After cleaning, the subject device reprocessed using a non-olympus automated endoscope reprocessor, soluscope series 4, with peracetic acid.Omsc is submitting three medical device reports according to the number of the infected patients.This is one of three reports.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus followed up with the user facility and was informed that the age of 3 patients, the date the patients underwent a procedure, and the patients¿ outcome.First patient: the patient was 82 years old and underwent a duodenoscopy using the subject device on (b)(6) 2019.It was reported that the patient¿s sepsis was getting better.The user facility decided to follow up with the patient condition and the patient is undergoing rehabilitation care.Second patient: the patient was 74 years old and underwent a duodenoscopy using the subject device on (b)(6) 2019.It was reported that the patient developed hypertonia and diabetes.It was also reported that the patient died on (b)(6) 2019, due to pancreas/peritoneal carcinosis that compressed the bile duct and the urinary tract.Third patient: the patient was 93 years old and underwent a duodenoscopy using the subject device on (b)(6) 2019.It was reported that the patient¿s condition was getting better.The user facility decided to follow up with the patient condition and the patient is undergoing rehabilitation care.In addition, olympus was informed that the user facility conducted the microbiological testing for the subject device on may 30th, 2019, and the testing result meet a requirement.In addition, olympus was informed that the last maintenance by olympus was carried out for the subject device on october 5th, 2018.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was sent to a third party laboratory (eurofins biotech-germande) and the laboratory carried out technical investigation.At the third party 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: -the adhesive was bleached.-there was extra glue on the distal end.-there was a scratch.-the parts of the adhesive were missing.After the disassembling, the microbiological testing for the surface of the subject device was conducted and the test results were as follow; -on the internal axis housing, pseudomonas aeruginosa (14cfu) -on the internal forceps elevator axis inside the external forceps elevator, pseudomonas aeruginosa (68cfu) -on the internal forceps elevator axis, pseudomonas aeruginosa (5cfu) -on the part of the internal forceps elevator axis, pseudomonas aeruginosa (2cfu) -on the air/water nozzle, coagulase-negative staphylococci (2cfu) -on the objective lens, coagulase-negative staphylococci (1cfu) -on the opposite side of the distal end cover, coagulase-negative staphylococci (1cfu) in addition, the microbiological testing for the channels of the subject device was conducted and the test results were as follows; the following is the result of sampling just after disassembling.-on the instrument channel and the suction channel, pseudomonas aeruginosa (3cfu) and coagulase-negative staphylococci (1cfu) -on the air/water channel, bacillus spp.(2cfu) and pseudomonas aeruginosa (2cfu) the following is the result of sampling just after the disassembled parts were stored for 48 hours at room temperature.-on the instrument channel and the suction channel, coagulase-negative staphylococci (1cfu) and pseudomonas aeruginosa (2cfu) -on the air/water channel, coagulase-negative staphylococci (1cfu) and corynebacterium (2cfu).The third party laboratory commented that the results could not identify clearly the contamination source.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, 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 192-8 507; JA 192-8507
• MDR Report Key: 8730280
• MDR Text Key: 149061249
• Report Number: 8010047-2019-02274
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170229503
• UDI-Public: 04953170229503
• Combination Product (y/n): N
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2019

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 the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/25/2019
• Supplement Dates Manufacturer Received: 06/17/2019; 08/29/2019
• Supplement Dates FDA Received: 07/16/2019; 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR