MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. GASTROSCOPE; GASTROINTESTINAL VIDEOSCOPE

Model Number UNKNOWN

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Manufacturer Narrative

The device was not returned.An olympus field service engineer went onsite and provided a reprocessing in-service.The customer reported that 7 scopes (3 gastroscopes and 4 colonovideoscopes) were reprocessed incorrectly.The model and serial numbers of the scopes were unknown and the information was unable to be obtained from the customer.Please refer to the following related events: unknown gastroscopes: (b)(4).Unknown colonovideoscopes: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported, the gastrointestinal videoscope was reprocessed without an auxiliary water channel connector, did not disinfect the lines, and did not know how to microtest the reprocessor.The issue occurred during reprocessing.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, an olympus field service engineer confirmed the reported information.However, several attempts were made to obtain additional information, but no response was received from the customer.Therefore, the root cause of the reported information is unable to be determined.As the serial number was not provided the device¿s instructions for use (ifu) cannot be reviewed.Please see below for oer-aw ifu statement which states: ifu: oer-aw in the related complaint instructs on the event as follows: chapter 4 basic endoscope reprocessing operations.4.8 connecting tube installation.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.Olympus will continue to monitor field performance for this device.

• Brand Name: GASTROSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• 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: 18810780
• MDR Text Key: 337635462
• Report Number: 9610595-2024-04289
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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