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

Model Number TJF-160VF

Device Problems Device Reprocessing Problem (1091); Fluid/Blood Leak (1250); Peeled/Delaminated (1454); Stretched (1601); Microbial Contamination of Device (2303); Material Twisted/Bent (2981)

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Date 04/06/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone number: (b)(6).The device referenced in this report was returned to olympus for evaluation.Preliminary findings are reported.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.Physical evaluation of the complaint device reveals: there is damage due to physical stress.The angle wires were stretched.There was insufficient cleaning of the device.There was damage to the angulation control lock/knob.The adhesive part on the bending rubber is worn out.Part of the insertion tube is caught and pinched.The device coating is peeling off likely due to aging/chemical stress.There is water invasion in the device.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported on an unspecified date, the evis exera duodenovideoscope was cultured and tested positive for pseudomonas.An unspecified time later, the scope was used for an endoscopic retrograde cholangiopancreatography (ercp).17 days after the ercp procedure, the patient presented with feverish peaks.Unspecified patient cultures were obtained.(results not provided) the duodenoscope was reprocessed and a culture was taken.The scope tested positive for pseudomonas.The patient was treated with antibiotic therapy.This event did not affect the patient's discharge from the hospital.Additional information has been requested regarding the patient and event.At this time, no additional information has been provided.

Manufacturer Narrative

This report is being updated to provide investigation findings.New information is reported in d8, g2, h4, h6, and h10.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: reprocessing manual:1.4 precautions: warning: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.Conclusion: the definitive cause of the reported events could not be established.Multiple attempts to gather additional information were made with no response from the customer.It is not known what the patient's culture results were (and if they were same as the scope-pseudomonas).The scope was reported to have tested positive for pseudomonas after being reprocessed, strongly suggesting insufficient reprocessing.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12048032
• MDR Text Key: 257887522
• Report Number: 8010047-2021-07853
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K024033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

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-160VF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/23/2021
• Supplement Dates Manufacturer Received: 01/12/2022
• Supplement Dates FDA Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2009
• 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): Required Intervention; Other