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

Model Number MAJ-2110

Device Problem Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Manufacturer Narrative

The serial number was not provided.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, during reprocessing, the connecting tube had cut at the black crimp.There was no harm or user injury reported due to the event.This report is related to a similar event captured in: patient identifier: (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the following patient identifiers for related complaints: (b)(6) (model number: maj-2110).(b)(6) (model number: maj-2111).(b)(6) (model number: maj-2113).(b)(6) (model number: maj-2112).(b)(6) (model number: oer-elite).(b)(6) (model number: maj-2110).(b)(6) (model number: maj-2110).(b)(6) (model number: maj-2110).(b)(6) (model number: maj-2110).(b)(6) (model number: maj-2111).(b)(6) (model number: maj-2112).(b)(6) (model number: maj-2112).(b)(6) (model number: maj-2113).(b)(6) (model number: maj-2113).The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The device was not returned for evaluation.However, based on the results of the investigation, it¿s likely the connector of connecting tube was unable to be connected as external stress was applied to the tube, which broke the connector.It¿s probable the root cause of the external stress is due to the user applying force 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: 16635538
• MDR Text Key: 312215781
• Report Number: 9610595-2023-05193
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 04/17/2023
• Supplement Dates FDA Received: 05/09/2023
• 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