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

Model Number MAJ-2113

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

The serial number is unknown at this time.The subject device has not been returned to olympus for evaluation.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported to olympus technical assistance center (tac), the grey side pieces of the connecting tube cracked and fell off.There was no harm or user injury reported due to the event.Patient identifier: (b)(6) capture related events.

Event Description

Additional information was received from the customer which confirmed the metal clips fell a part over time from use.The exact event date is unknown, however, the customer confirmed it occurred within the past 30-60 days.There were no error messages observed as a result of the failure.There was no impact to the patient.Additionally, it was reported that the provider may have downtime or reduced washing abilities waiting on replacement connectors.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and the device evaluation.Please see updates to b5, d4, d8, d9, h3, h6 and h10.H4: based on the 3 digit lot number provided, the manufacturing date of the device was in the month of february 2013 but a specific date could not be identified.The device was returned to olympus for inspection, and the customer's complaint was confirmed.Visual inspection of the reprocessor side (orange) connector observed one gray lock lever and its metal clip missing, but the remaining lock lever and the pin inside the connector are intact.There were no cracks on the connecting tube, and its tubing had no moisture stains or residues inside.The reprocessor side connector was snapped into the orange connector on our test reprocessor and able to stay in place.The endoscope side connector was also connected firmly into the test endoscope¿s auxiliary water inlet without a problem.The device history record was unable to be reviewed for this device as only the 3-digit lot number was 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, it¿s likely that external stress was applied to lock lever of connecting tube, which broke the lever and the tube was unable to be connected.Additionally, it's probable the external stress was due to a force that was applied in incorrect direction.The final root cause of this event was unable to be identified.The event can be detected by following the instructions for use which state: ¿9 preparation and inspection 2 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.

• 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: 16834907
• MDR Text Key: 314466772
• Report Number: 9610595-2023-06885
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170404085
• UDI-Public: 04953170404085
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

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-2113
• Device Lot Number: 32A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 05/24/2023
• Supplement Dates FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• 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