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

Model Number TJF-160VR

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

Patient Problem Unspecified Infection (1930)

Event Date 03/01/2019

Event Type  Injury  

Manufacturer Narrative

Olympus reviewed the service history for the subject device.The olympus (b)(4).((b)(4)) subsidiary had received the subject device for repair from the user facility in march 2019 before aware of the reported event.The evaluation results of the subject device by the (b)(4) are as follows: there was an air leakage from the distal end.The instrument channel had wear and scratches.The adhesive of the rubber of the bending section had a wear and a tear.There were scratches on the distal end.There were scratches on the light guide lens.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 the samples collected from five patients were tested positive for klebsiella spp, carbapenemase-producing enterobacteriaceae (cpe), new delhi metallo-beta-lactomase (ndm) or klebsiella pneumoniae after a procedure using an olympus duodenoscope (tjf-160vr) between (b)(6) 2019 and (b)(6) 2019.First patient: the patient underwent a procedure for replacement of prosthesis after a migration using the subject device on (b)(6) 2019.It was reported that klebsiella spp, cpe and ndm were detected from the bile sample collected from the patient.Second patient: the patient underwent an endoscopic retrograde cholangiopancreatography (ercp) using the subject device on (b)(6) 2019.It was reported that cpe, ndm and klebsiella pneumoniae were detected from the bile and rectal samples collected from the patient.Third patient: the patient underwent a procedure for replacement of prosthesis using the subject device on (b)(6) 2019.It was reported that klebsiella pneumoniae, cpe and ndm were detected from the rectal sample collected from the patient.Fourth patient: the patient underwent an ercp using the subject device on (b)(6) 2019.It was reported that klebsiella pneumoniae, cpe and ndm were detected from the bile sample collected from the patient.Fifth patient: the patient underwent a procedure for replacement of biliary prosthesis using the subject device on (b)(6) 2019.It was reported that klebsiella pneumoniae, cpe and ndm were detected from the rectal sample collected from the patient.Five patients were colonized cpe.The device had been reprocessed with a non-olympus automated endoscope reprocessor, soluscope serie 3, using peracetic acid.Omsc is submitting five medical device reports according to the number of the patients.This is three of five reports.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The initial mdr reported that five patient were infected with organisms.On june 27th, 2019, olympus medical systems corp.(omsc) was informed that the sample collected from another patient was tested positive for carbapenemase-producing enterobacteriaceae (cpe), new delhi metallo-beta-lactomase (ndm) or klebsiella pneumoniae after an endoscopic retrograde cholangiopancreatography using olympus duodenoscope (tjf-160vr) on (b)(6) 2019.The condition of the sixth patient involved in the event is currently unknown.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.On may 28th, 2019, olympus followed up with the user facility and received additional information as follows; the endoscope unit of the user facility has permitted to use the subject device after the repair.There was no proof to show the association between infection and subject device.The user facility has not carried out antibiotic treatment for the patients.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 correct the section b3 ¿date of event¿.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.On (b)(6) 2019, olympus medical systems corp.(omsc) was informed that as a result of the last microbiological testing by the user facility before the infection occurred, the subject device tested positive for unspecified microbes (2cfu/50ml).The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.

• Brand Name: EVIS EXERA 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: 8547678
• MDR Text Key: 143038638
• Report Number: 8010047-2019-01827
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• PMA/PMN Number: K024033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/03/2019

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-160VR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 05/28/2019; 06/27/2019; 08/05/2019; 08/07/2019
• Supplement Dates FDA Received: 06/21/2019; 07/24/2019; 08/26/2019; 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other