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

Model Number	MAJ-2330
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
Additional Manufacturer Narrative
H4: the subject device was manufactured on december, 2020 based on the provided 3 digit lot information.Therefore, 01dec2020 was selected.The subject device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The connecting tube could not be connected to connector in reprocessing basin due to detachment of lock lever.The lock levers and metal clips detached/missing from the plastic reprocessor connector (these were not returned for evaluation).The technician was unable to test the connecting tube with the oer-elite reprocessor due to the missing/detached lock levers and metal clips.In addition, there was no damage noted with the plastic endoscope connector on the connecting tube.The movement on the plastic endoscope connector lever was normal and smooth.There were also no damages observed with the plastic clear tube or scratches/dents/nicks with the plastic connector.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, it is likely that 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): "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.
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): this report (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).

• 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: 17042668
• Report Number: 9610595-2023-08287
• Device Sequence Number: 12044682
• Product Code: FEB
• UDI-Device Identifier: 04953170404207
• UDI-Public: 04953170404207
• 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): 06/01/2023

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-2330
• Device Lot Number: 0ZA
• 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: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• 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