MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOSCOPE REPROCESSOR

Model Number OER-5

Device Problem Failure to Clean Adequately (4048)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/16/2024

Event Type  malfunction  

Manufacturer Narrative

E1:(b)(6).The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.Related patient identifiers: (b)(6).

Event Description

Olympus was informed that the wire channel of the forceps lifter was not cleaned by manual cleaning.The dedicated cleaning tube was not used when cleaning the endoscope reprocessor and was used for the next patient's examination.It was unclear how it was discovered that the device had not been cleaned.The device was used on one patient without adequate reprocessing.No patient infections or injuries reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the user did not thoroughly read the instruction for use (ifu) manual, and reprocessing was performed without attaching a connecting tube.However, the root cause could not be determined.The event can be detected/prevented by following the ifu which state: ¿section 4.7 - connecting tube installation: to find out what connecting tubes can be used, refer to the provided ¿list of compatible endoscopes/connecting tubes.¿ warning attach all of the connecting tubes specified according to the type of the endoscope.If reprocessing is performed without attaching all of the required connecting tubes, reprocessing may be ineffective.Although the ¿list of compatible endoscopes/connecting tubes¿ shows the applicable connecting tubes for each endoscope, it may not list the latest endoscope models.If your endoscope model is not listed, contact olympus for more information.¿ this supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19194359
• MDR Text Key: 341571399
• Report Number: 9610595-2024-08761
• Device Sequence Number: 1
• Product Code: FEB
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 05/14/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2020
• 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: JF-260V; MAJ-1971