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

Model Number	MAJ-1516
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned to any of olympus locations.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.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed from the field service engineer of olympus, that it was found a pin inside the equipment side connector (resin) of the subject device was broken and had been gone when visiting the user facility.The subject device had been used with an olympus automated endoscope reprocessor model oer-5.It was unknown when the issue had been occurred.There was no patient injury associated with this report.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.Since the subject device was not returned to olympus medical systems corp.(omsc), it could not be investigated.Based on the report of the field service engineer of olympus, omsc determined that the that the cleaning tube of the subject device was used for cleaning and disinfection with the pins of the connector damaged.The cause of the damage of the pin of the connector of the cleaning tube might have occurred due to deterioration of the resin with long-term use.If additional information becomes available, 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: 12075359
• Report Number: 8010047-2021-08069
• Device Sequence Number: 4428723
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

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-1516
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1