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

Model Number	MAJ-2115
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem 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): this report; (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).
Additional Manufacturer Narrative
H4: the subject device was manufactured on january, 2021 based on the provided 3 digit lot information.Therefore, 01jan2021 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.The device was returned to olympus for evaluation and the customer's allegation was not confirmed.The device evaluation was unable to find any issues connecting the (blue) plastic connector connecting tube device onto the b1 ports of the oer-elite reprocessor.The connecting tube (blue) plastic connector was connected and disconnected multiple times on the b1 ports of the oer-elite reprocessor and there were no signs of the lock levers/metal clips and (blue) plastic connector coming off/popping off/coming apart.The click sound was verified and secured when connecting the blue plastic connector to the b1 port as well.The following findings were observed, however are considered non-critical and therefore do not present a potential for harm: there was scratches and stains noted on the (blue) plastic connector.There were also scratches noted on the metal connector.Based on the results of the investigation, there was no abnormality with the connecting tube.Therefore, it is likely that the tube was not pushed enough (until it clicked) during connection or foreign material or the like got caught between the connecting part, which made the tube unable to be connected.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
• Common Device Name: 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: 17085896
• Report Number: 9610595-2023-08581
• Device Sequence Number: 14189194
• Product Code: FEB
• UDI-Device Identifier: 04953170404108
• UDI-Public: 04953170404108
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K190969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2023

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
• Operator of Device: Health Professional
• Device Model Number: MAJ-2115
• Device Lot Number: 11A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCOPE REPROCESSOR, OER-ELITE, SN# (B)(6).
• Patient Sex: Unknown