MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. CONNECTING TUBE; ENDOSCOPE REPROCESSOR ACCESSORIES

Model Number MAJ-2110

Device Problem Degraded (1153)

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

Event Date 09/15/2022

Event Type  malfunction  

Event Description

The customer reported to olympus that the connecting tube of the endoscope reprocessor was falling apart.There was no patient harm associated with the event.

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation was confirmed.It was found that one side of the gray lock levers and one side of the metal clips were missing, missing gray lock lever and metal clip were not returned for evaluation.In addition, there were white spots inside the tube and scratches noted outside of the tube-connecting tube.Additionally, there were observed scratches, dents/nicks on the metal connector of the connecting tube and nicks/dents on the blue plastic connector.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, it¿s likely the connecting tube could not be connected due to detachment of the lock lever by external stress.As a cause of the external stress, the user may have applied force toward incorrect direction.A final root cause of the event was unable to be identified.The event can be detected by following the instructions for use which state: ¿preparation and inspection: move the lock levers of the reprocessor side connector to make sure that they function properly and are not broken.¿ olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide h4.H4: based on the 3digit lot number the manufacturing date of the device was in the month of august 2012, but a specific date could not be identified.The device history record was unable to be reviewed for this device because only the 3 digit lot was provided and the manufacturing date is unknown.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.

• Brand Name: CONNECTING TUBE
• Type of Device: ENDOSCOPE REPROCESSOR ACCESSORIES
• 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: 15997030
• MDR Text Key: 306106409
• Report Number: 9610595-2022-05591
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170404054
• UDI-Public: 04953170404054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2023

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: MAJ-2110
• Device Lot Number: 28A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 12/27/2022; 12/27/2022
• Supplement Dates FDA Received: 01/24/2023; 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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-ELITE