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

Model Number	MAJ-2118
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.If full information becomes available, the manufacturer date will be updated.The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found one side of the lock levers and metal clips detached/missing from both plastic (blue) reprocessor connectors.Both lock levers and metal clips were not returned for evaluation.However, one side of the lock levers and metal clips was still fully intact from both plastic connectors.Further testing could not be performed due to the missing/detached lock levers and metal clips.The following findings were observed, however are considered non-critical and therefore do not present a potential for harm: there were scratches on both (blue) plastic connectors and scratches on both plastic tubes of the device.Scratches were also observed on the metal connector.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported to olympus, the connecting tube cannot be connected to the channel connector in the reprocessing basin.The customer stated the connectors are falling apart.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).
Additional Manufacturer Narrative
This report is being supplemented to correct h10 dhr statement.A review of the device history record (dhr) could not be completed since the manufacturing date of the subject item is unknown.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the full serial 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 lock lever of connecting tube, which broke the lever and the tube was unable to be connected.As a cause of the external stress, the user may have applied force toward incorrect direction.The event can be prevented 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
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17013694
• Report Number: 9610595-2023-08125
• Device Sequence Number: 20565152
• Product Code: FEB
• UDI-Device Identifier: 04953170404139
• UDI-Public: 04953170404139
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2023

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-2118
• 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
• Supplement Date Received by Manufacturer: 06/01/2023; 06/01/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 06/12/2023; 06/12/2023
• 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: OER ELITE REPROCESSOR.
• Patient Sex: Unknown