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

Model Number MAJ-2112

Device Problems Break (1069); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation of the green connector on the connecting tube being broken was confirmed.The device evaluation found one lock levers and metal clips were detached from the blue plastic connector.Market quality was unable to test the connecting tube with the oer-elite reprocessor machine due to the missing/detached lock levers and metal clips.Also found were scratches on the blue plastic connector and also scratches and nicks were noted on the metal connector.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus, the green connector pin on the connecting tube was broken upon receipt.The issue was found during reprocessing.There were no reports of patient involvement.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, as well as corrections to e2, e3, and g2.The information included in e2, e3, and g2 was inadvertently omitted from the initial medwatch report.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it¿s likely the lock lever on the connecting tube was broken due to external stress that was applied to the tube.It¿s likely the external stress was caused by the user applying stress in an 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: ¿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.

• 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: 17195457
• MDR Text Key: 317830367
• Report Number: 9610595-2023-09267
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170404078
• UDI-Public: 04953170404078
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-2112
• Device Lot Number: 32A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• 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