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

Model Number MAJ-2138

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

The customer reported to olympus that the connecting tube cannot be connected to the channel connector in the reprocessing basin.The customer stated the connectors are falling apart.The connectors became detached too easily and at times, the connector hook becomes detached from the connector.There was a metal clip in the clasps that falls off, causing the plastic ¿wings¿ to come off the connector.There was no patient harm associated with the event.The medical device report (mdr) is related to the following patient identifiers: (b)(6) (model number: maj-2330); (b)(6) (model number: maj-2330); (b)(6) (model number: maj-2330); (b)(6) (model number: maj-2330); (b)(6) (model number: maj-2118); (b)(6) (model number: maj-2118); (b)(6) (model number: maj-2118); (b)(6) (model number: maj-2118); (b)(6) (model number: maj-2115); (b)(6) (model number: maj-2115); (b)(6) (model number: maj-2115); (b)(6) (model number: maj-2115); (b)(6) (model number: maj-2114); (b)(6) (model number: maj-2114) (b)(6) (model number: maj-2114); (b)(6) (model number: maj-2114); (b)(6) (model number: maj-2116); (b)(6) (model number: maj-2116); (b)(6) (model number: maj-2116); (b)(6) (model number: maj-2116); (b)(6) (model number: maj-2138); (b)(6) (model number: maj-2138); (b)(6) (model number: maj-2138); (b)(6) (model number: maj-2138): this report.

Manufacturer Narrative

H4: the subject device was manufactured on december, 2020 based on the provided 3 digit lot information.Therefore, 01dec2020 was selected.The device history record was unable to be reviewed for this device since the full lot number was not 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, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.However, it is likely one of the following scenarios may have occurred: 1.The tube was not pushed enough (until it clicked) during connection or foreign material got caught between the connecting part, which made the tube unable to be connected.2.External stress was applied to the lock lever of the connecting tube, which broke the lever and the tube was unable to be connected.The cause of external stress may have been from the user applying force toward incorrect direction.The user can detect the event by conducting inspection as follows per the instructions for use (ifu): "9.Preparation and inspection: move the lock levers of the reprocessor side connector to make sure that they function properly and are not broken.5.6 inspecting the connectors connect each connector firmly by pushing until the connector clicks into place.After connection, pull the connector gently to confirm that it cannot be disconnected easily." 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17097393
• MDR Text Key: 317489273
• Report Number: 9610595-2023-08651
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170404184
• UDI-Public: 04953170404184
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2023

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-2138
• Device Lot Number: 0ZA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: ENDOSCOPE REPROCESSOR, OER-ELITE, SN# (B)(6)