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

Model Number JF-260V

Device Problem Device Reprocessing Problem (1091)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

The customer reported two olympus endoscopes were used on patients and the facility suspects an unknown number of patients may be infected.Additional information is being requested.This is for scope 2 of 2 for an unknown number of patients.

Manufacturer Narrative

The suspect device has been returned to olympus for evaluation.The investigation is in process.The subject device was cultured and did not have microbial contamination.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the device evaluation, the legal manufacturer¿s investigation and the device history record (dhr) review.New information was added to the following fields: h3, h6, h10.Inspection of the returned device found chipping of the bending section cover glue as well as cutting and crushing of the insertion tube.The insertion tube boot and the boot of the control section side were scratched.In addition, the bending angle was insufficient, the angle wires were stretched, and a whitish color of the objective lens glue was noted.The dhr for this device was reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The following deviations of reprocessing methods from the instructions for use (ifu) were confirmed: ·manual cleaning was not performed while the endoscope was immersed into detergent solution.·the forceps elevator was not raised/lowered three times while the endoscope was immersed into detergent solution.·detergent solution was not supplied into the forceps elevator.·water filter of the automated endoscope reprocessor was not replaced within the specified period.·as a result of checking the subject device, any irregularity such as air leak, scratches inside the channel, or stain were not confirmed.A definitive root cause was not identified.Based on the available information, the legal manufacturer could not determine the relationship between the subject device and infection.Detailed information about the infected patients was unable to be determined, and the result of the culture test of the subject device was negative.The ifu states the following: if the endoscope is not cleaned meticulously, effective disinfection or sterilization may not be possible.Clean the endoscope and accessories thoroughly before disinfection or sterilization to remove microorganisms or organic material that could reduce the efficacy of disinfection or sterilization.Olympus will continue to monitor the field performance of the device.

• Brand Name: EVIS LUCERA 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: 14940255
• MDR Text Key: 295405125
• Report Number: 8010047-2022-11432
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JF-260V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2011
• 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
• Treatment: OER-3 OR OER-4
• Patient Outcome(s): Other