MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. CONNECTING TUBE; LUMINAL DEVICE FLUSHING TUBING SET, REUSABLE

Model Number MAJ-2110

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Date 12/12/2022

Event Type  malfunction  

Event Description

Olympus sales support representative reported that the tabs on the connector to the maj-2110 broke off.According to the report, the customer was returning the defective product.There is no patient involvement on this reported event.No user injury was reported.

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation , a visual inspections was performed on the as is received condition , found that the connecting tube was not returned in its original packaging.Evaluation confirmed that a gray clip was missing on the blue connector and was not returned for evaluation.The pin of the blue connector is intact and has no signs of damage.The other metal connector on the connecting tube has several scratches on the housing.The tubing was examined and there were no signs of punctures, residue, or corrosion identified inside the tubing.A functional tests was unable to be performed as one of the gray clips is missing.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

H4: the subject device was manufactured in december 2020, but the specific date is unknown at this time.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the root cause could not be determined, however, it is possible that external load was applied to the cleaning tube, causing the lock lever to come off and make connection impossible.An external load on the irrigation tube may be caused by applying a force in the wrong direction.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: LUMINAL DEVICE FLUSHING TUBING SET, REUSABLE
• 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: 16135735
• MDR Text Key: 308743913
• Report Number: 9610595-2023-00568
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

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: 0ZA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 01/11/2023
• Supplement Dates Manufacturer Received: 01/23/2023
• Supplement Dates FDA Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• 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