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

Model Number	MAJ-2117
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 july, 2022 based on the provided 3 digit lot information.Therefore 01jul2022 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 the lock levers on the reprocessor side connector were broken off.The endoscope side connector had several minor scratches on the metal housing of the connector.Functional tests could not be performed as the lock levers on the reprocessor side connector were broken off.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 side connectors crack and fall off.The issue was found during reprocessing.There were no reports of patient harm.This medical device report (mdr) is related to the following patient identifiers: (b)(6), (maj-2117, this report) (b)(6), (maj-2111) (b)(6), (maj-2110) (b)(6), (maj-2330) (b)(6), (maj-2110).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to h6 and h10.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.Based on the results of the investigation, it¿s likely that external stress was applied to lock lever of connecting tube, which broke the lever and the tube was unable to be connected.Additionally, it's probable the external stress was due to a force that was applied in 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: ¿9 preparation and inspection.3 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: 17035121
• Report Number: 9610595-2023-08234
• Device Sequence Number: 17869720
• Product Code: FEB
• UDI-Device Identifier: 04953170404122
• UDI-Public: 04953170404122
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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-2117
• Device Lot Number: 27A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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
• Patient Sex: Unknown