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

Model Number MAJ-2114

Device Problem Separation Problem (4043)

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

Event Date 10/21/2022

Event Type  malfunction  

Manufacturer Narrative

Related patient identifiers: the customer reported that multiple connecting tubes were bad.(b)(6) (addresses model number maj-2110; lot# 0ya), (b)(6) (addresses model number maj-2112; lot# 0za), (b)(6) (addresses model number maj-2113; lot# 0ya) (b)(6) (addresses model number maj-2114; lot# 0ya, (b)(6) (addresses model number maj-2115; lot# 0xa and (b)(6) (addresses model number maj-2330; lot# 0xa).The customer reported that the connectors will be returned.However, to date, the connecting tube has not been returned.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus technical assistance center (tac), there were multiples oer-elite connectors that were ¿bad¿.The customer reported that it was an out of box failure.There was no patient involvement.

Event Description

Customer confirmed all the connectors broke at the metal clips.

Manufacturer Narrative

This report is being submitted to provide additional information based on the legal manufacturer¿s final investigation, device evaluation, customer follow-up and g3 correction.B5: updated with information received from the customer.Correction to g3 of the initial medwatch.The aware date should be 29-aug-2022.The subject device was manufactured in november, 2010 but an exact date is unavailable as the complete serial number was not provided.The device history record was unable to be reviewed for this device since the complete serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The olympus service center received the returned devices and confirmed the damaged connecting tube.Based on the results of the device investigation, the root cause of the event could not be determined, however, this issue was found to likely be the result of an external load applied to the cleaning tube, making it impossible to connect.An external load on the irrigation tube may be caused by the user applying force in the wrong direction.The event can be prevented by following the instructions for use which state: ¿abnormalities can be detected by conducting the following inspections: 9.Preparation and inspection 2.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.

Manufacturer Narrative

This report is being supplemented to provide a correction to the legal manufacturer's final investigation.Based on the results of the corrected investigation, there has since been a design change to prevent reoccurrence.

• Brand Name: CONNECTING TUBE
• Type of Device: 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: 15831066
• MDR Text Key: 307890564
• Report Number: 9610595-2022-04319
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170404092
• UDI-Public: 04953170404092
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2023

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-2114
• Device Lot Number: 0YA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/21/2022
• Initial Date FDA Received: 11/19/2022
• Supplement Dates Manufacturer Received: 01/05/2023; 03/14/2023
• Supplement Dates FDA Received: 02/04/2023; 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1