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 Consequences Or Impact To Patient (2199)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to omsc for evaluation.Omsc checked the subject device and found that the connecting tube connector of the endoscope side was disconnected, but found that the subject device functioned without any problem such as poor durability against pulling, and also found that there was no abnormality on the exterior.Based on the result of the omsc evaluation, omsc concluded that the reported phenomenon occurred accidentally during the reprocessing due to the accumulation of stress, which might be caused by the long-term use of the subject device, the hit against something other than the subject device, or the user's handling with holding the slide portion of the subject device.If additional information becomes available, 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 connector was disconnected.The user facility did not provide other detailed information.There was no report of patient injury associated with this event.

• 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: 10989452
• Report Number: 8010047-2020-10206
• Device Sequence Number: 3487082
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2020

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: 11/19/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1