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

Model Number	MAJ-2118
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The olympus sales representative, reported on behalf of the customer, the customer was having a hose connection failure on the endoscope reprocessor for the following connection tubes: maj-2110, maj-2111, maj-2112,maj-2330,maj2114,maj-2115, maj-2117 and maj-2118.The connectors keep coming off.The connecting tubes are reportedly being returned to olympus for evaluation.There was no report of patient harm associated with this event.
Additional Manufacturer Narrative
To date, the connectors have not been returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.As the lot number hasn¿t been provided the device has not been returned, both a device history record found and device evaluation was not able to be performed.Based on the results of the investigation, it is likely that the following led to the malfunction: a) external stress was applied to the connecting tube.B) stress applied to the connecting tube such as hitting a hard object to the item and/or applied force toward the wrong direction by the user.A definitive root cause cannot be identified.This issue is addressed in the instructions for use (ifu): abnormality is detectable by performing the following inspection.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 the field performance of this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information regarding this event, refer to b5 and h6.
Event or Problem Description
Additional information was received regarding this event.It was confirmed with the customer's sales representative that the connectors on the oer-elite and the connecting tubes were broken.The oer-elite was not broken.The sales representative is currently looking at replacing the adapters with the newer model that mimics the former oer pro make.
Additional Manufacturer Narrative
This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is (b)(4).

• 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: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14952373
• Report Number: 8010047-2022-11554
• Device Sequence Number: 20207992
• Product Code: FEB
• UDI-Device Identifier: 04953170404139
• UDI-Public: 04953170404139
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/04/2024

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
• Was Device Available for Evaluation?: Yes
• 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: 06/07/2022
• Supplement Date Received by Manufacturer: 10/04/2022; 12/01/2022; 06/04/2024
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 11/04/2022; 12/29/2022; 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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