MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CONNECTING TUBE; ENDOSCOPE REPROCESSOR ACCESSORIES

Model Number MAJ-1500

Device Problems Device Reprocessing Problem (1091); Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/23/2021

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed from the field service engineer of olympus that it was found something like water stain at the tip of the insertion part of the endoscope (gif-2tq260m) when it was conducted the periodic inspection at the user facility.This indicated that the user may have used the poor reprocessing subject device for next procedure.The user uses an olympus automated endoscope reprocessor model oer-4 after brushing.In addition, the user also informed and concerned as followings; since there were no abnormalities with other endoscopes, it was said that there was no problem with brushing and cleaning procedures.The user concerned that the owned connecting tubes (maj-1500/the subject device, maj-1503, maj-1971) connected to the washer may be related to this phenomenon that they float during cleaning.There was no abnormality in the appearance of the tube during cleaning, but it floated during cleaning.There was concern that the connecting tube may have become shorter due to deterioration of direct sunlight, the claws of the cleaning tube may have become worse, or there may have been some initial failure.There was no report of patient injury associated with the event.(this report is for the connecting tube (maj-1500), which was used in combination.).

Manufacturer Narrative

The subject device is planned to be returned to olympus but has not been returned to olympus yet.Therefore, olympus could not investigate the subject device.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct information provided on the initial report.The following section was corrected: g2.The device lot number and manufacture date are unknown; therefore, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the legal manufacturer's investigation, the actual product that was sent was inspected and it was confirmed that the pin of the connector attached to the reprocessor side was made of resin.It was found that this washing tube was manufactured before 2016.No abnormalities in hooks of the connector were found, the length of the tube satisfied the standard value, therefore, no problems were confirmed.The actual device was assembled to an olympus scope for inspection and performed the programming process, hard water residue was not generated at the distal end of the insertion section of the scope.Additionally, the washing tube did not float during the programming process.The root cause was not identified.Based on the investigation results, it was noted that there was the possibility that hard water residue adhered to the scope due to insufficient wiping of the distal end when wiping the scope after reprocessing.Also, regarding the event of the washing tube that floated, it was likely due to it not being properly attached to the scope during the reprocess.Olympus will continue to monitor field performance for this device.

• Brand Name: CONNECTING TUBE
• Type of Device: ENDOSCOPE REPROCESSOR ACCESSORIES
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13301038
• MDR Text Key: 295349110
• Report Number: 8010047-2022-01677
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170233937
• UDI-Public: 04953170233937
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2022

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-1500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/23/2021
• Initial Date FDA Received: 01/20/2022
• Supplement Dates Manufacturer Received: 06/09/2022
• Supplement Dates FDA Received: 06/23/2022
• 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: Reuse
• Patient Sequence Number: 1