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

Model Number MAJ-1500

Device Problems Device Contamination with Chemical or Other Material (2944); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2021

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 252333451
• Report Number: 8010047-2021-06630
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170233937
• UDI-Public: 04953170233937
• Combination Product (y/n): N
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1