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

Model Number	MAJ-1500
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that when cleaning with the endoscope reprocessor and connecting tube, cleaning was performed without attaching the connector on the endoscope side of the cleaning/connecting tube (the mouth of the tube that connected to the forceps mouth).The customer had inquired about how much aceside and detergent remained around the forceps opening and in the channel.The customer further stated that they knew the scope was not disinfected, they didn't know how long cleaning had been done like this or what type of scope was cleaned.It was unknown if any patient's had been infected.The site had recent changes in staff and the customer suspected this may have resulted in the insufficient cleaning.There was no reported patient harm or impact due to this event.
Additional Manufacturer Narrative
The scopes, endoscope reprocessors, and cleaning tubes involved in the event were unknown.Reports are being submitted on all scopes, endoscope reprocessors, and cleaning tubes at the site.Please refer to the following reports: patient identifier of (b)(6) is related to model number: oer-5, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: oer-5, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: oer-5, serial number: 2201450 patient identifier of (b)(6) is related to model number: maj-1500, lot number: na.Patient identifier of (b)(6) is related to model number: maj-1500, lot number: na.Patient identifier of (b)(6) is related to model number: maj-1500, lot number: na.Patient identifier of (b)(6) is related to model number: maj-1500, lot number: na patient identifier of (b)(6) is related to model number: maj-1500, lot number: na.Patient identifier of (b)(6) is related to model number: maj-1500, lot number: na.Patient identifier of (b)(6) is related to model number: jf-260v, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: jf-240, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: gif-xq260, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: gif-xp290n, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: gif-xp290n, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: gif-xp290n, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: gif-xp260n, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: gif-q260j, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: gif-q260, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: gif-hq290, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: gif-h290z, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: gif-h290, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: gif-h290, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: gif-h290, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: gif-h290, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: gif-1200n, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: cf-hq290i, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: cf-hq290i, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: cf-hq290i, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: cf-h260ai, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: pcf-h290zi, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: pcf-h290i, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: pcf-h290i, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: pcf-h290i, serial number: (b)(4).This event is under investigation.A supplemental report will be submitted upon receiving additional information.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to h3.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 the incorrect reprocessing occurred due to staff changes and the customer not following the instructions for use.The final root cause of this event was unable to be identified.The event can be detected and prevented by following the instructions for use which state: ¿chapter 8 operation¿ for maj-1500: for operations other than connecting and disconnecting the connecting tube, refer to the instruction manual for the endoscope reprocessor.For operations of other connecting tubes that may be required for cleaning and high-level disinfecting the endoscopes, refer to the instruction manual for the respective tubes.Be sure to connect the connecting tube properly.If the connecting tube is connected incorrectly, you may observe excessive fluid at the lid and/or it may reduce the effectiveness of the cleaning and disinfection of the endoscope.¿ 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: 16643015
• Report Number: 9610595-2023-05271
• Device Sequence Number: 12286452
• Product Code: FEB
• UDI-Device Identifier: 04953170233937
• UDI-Public: 04953170233937
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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-1500
• Was Device Available for Evaluation?: No
• 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: 03/03/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 05/10/2023
• 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