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

Model Number	MAJ-1516
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.
Event or Problem Description
During inspection prior to use, the device's lock lever didn't fit in with automated endoscope reprocessor.The customer used another connecting tube to complete the reprocessing.There was no report of patient injury associated with the 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 could not review the manufacturing history (dhr) of the subject device because the lot number of the device is unknown.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the investigation result by omsc there was the possibility that the reported phenomenon was attributed to the accidental external force applied to the lock lever such as during transportation.

• 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: 10360192
• Report Number: 8010047-2020-05215
• Device Sequence Number: 19555204
• Product Code: FEB
• UDI-Device Identifier: 04953170234057
• UDI-Public: 04953170234057
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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: No Information
• Device Model Number: MAJ-1516
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement 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