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

Model Number	MAJ-1500
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
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 during the reprocessing of the unspecified endoscope with the subject device (connecting tube maj-1500), it was found that the subject device was clogged with foreign material such as something like a translucent adhesive, and there was no fluid flow through the subject device, which connected the automated endoscope reprocessor oer-5 (not available in the usa) to the endoscope.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 reported foreign object was returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacture history (dhr) of the subject device and confirmed no irregularity.Omsc checked the foreign object and found that it was a translucent, flat, and long rubber-like object.And, as a result of organic qualitative analysis, it was found that the foreign object was a silicon-based substance similar to the sealant applied to the threaded portion of the connector of the reprocessing basin.And, it was also found that there was no or little possibility of generation/invasion of the detected substance in the assembly process using the sealant.The exact cause of the reported event could not be conclusively determined.However, based upon the investigation result, it was surmised that during the manufacturing/repairing of other device used in combination with the subject device (connecting tube maj-1500), the sealant (hardened material) accidentally invaded the pipeline of the other device, flowed to the connector of it due to the flowing liquid, and invaded the subject device.Alternatively, it was also surmised that during using the subject device at the user facility, a silicone-based substance similar to the sealant invaded the pipeline of the subject device, flowed to the connector of it due to the flowing liquid, and invaded the subject device.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: 11868406
• Report Number: 8010047-2021-06630
• Device Sequence Number: 13664272
• 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: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2021

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: 05/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 05/22/2021
• Supplement Report FDA Received Date: 06/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1