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

Model Number	MAJ-1500
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to omsc for evaluation.However, the investigation is in progress at this time.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.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed from the user facility that after the reprocessing of the unspecified endoscope with the subject device, it was found that the connecting tube was disconnected from the connecting tube connector.The user facility replaced the subject device to another connecting tube and reprocessed the endoscope again, because there was concern about detergency.This issue occurred with three connecting tubes (maj-1500) including the subject device in this report.There was no report of patient injury associated with this event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc checked the subject device and found the followings.As a result of checking the connection and disconnection of the subject device with the endoscope reprocessor and the endoscope, it was found that there was no abnormality such as disassembling of components or disconnecting from the connecting tube connector as reported.As a result of checking the exterior of the subject device, it was found that there was a larger gap between the connecting tube connector and the connecting tube than when the subject device had been manufactured, and that some components had been installed in the improper direction.Therefore, it was surmised that the stress applied to the subject device by user handling, and that the subject device had been reassembled at the user facility.As a result of disassembling and checking the connection section of the subject device, it was found that there was no damage, cracks, breaks, deformation, or other abnormalities in the disassembled connectors, tubes, and ring-shaped plastic components.The exact cause of the reported event could not be conclusively determined.However, based upon the reported information and the investigation results, it was surmised that the subject device had been easily disassembled (loosely assembled) due to the accumulation of stress during handling or unintentional application of strong stress, and then the subject device could not withstand the air and water feed pressures during reprocessing, and consequently the connecting tube was disconnected from the connecting tube connector as reported.If additional information is received, this report will be supplemented.

• Brand Name: CONNECTING TUBE
• Common Device Name: ENDOSCOPE REPROCESSOR ACCESSORIES
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11654046
• Report Number: 8010047-2021-04860
• Device Sequence Number: 11818570
• 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: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1