MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. CONNECTING TUBE

Model Number MAJ-1971

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2022

Event Type  malfunction  

Manufacturer Narrative

Reports are being submitted on the scopes and the clogged connecting tube that were reprocessed using the oer-4.Please refer to the following reports: patient identifier of (b)(6) is related to model number: maj-1971, serial number: unknown 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: gif-q260j, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: pcf-q260ji, serial number: (b)(4).The oer-4 was used as the automatic endoscope reprocessor (aer) at the site.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported the oer-4 automatic endoscope reprocessor (aer) and connecting tube were used to wash a scope.When washing the scope, the connecting tube was clogged and it was possible that the auxiliary water pipe and channel could not be washed.It was unknown if the insufficiently cleaned scope was used on a patient.There was no reported patient harm or impact due to this event.The clogging was resolved and the scope was cleaned again without problems.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation and correction to g2.The device history record was unable to be reviewed for this device since the serial number was not provided due to it being an accessory device.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 foreign material entered the connecting tube which led to clogging of the connecting tube.A final root cause of the tube clogging could not be determined.The following is included in the instructions for use: "chapter 8 preparation and inspection¿ of the instruction manual of maj-1971." olympus will continue to monitor field performance for this device.

• Brand Name: CONNECTING TUBE
• Type of Device: CONNECTING TUBE
• 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: 15851468
• MDR Text Key: 307709876
• Report Number: 9610595-2022-04471
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170329623
• UDI-Public: 04953170329623
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

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
• Device Operator: Health Professional
• Device Model Number: MAJ-1971
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 12/16/2022
• Supplement Dates FDA Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1