MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS ENDOSCOPE REPROCESSOR

Model Number OER-6

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/20/2021

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during the reprocessing, adhesion of black foreign matter was confirmed on the water level sensor and an error occurred due to the effect.There was no report of patient injury associated with the event.

Manufacturer Narrative

The subject device was returned to omsc for evaluation.The evaluation is in progress currently.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.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) checked the foreign matter and found that it was black solid substance and became powdery state when crushed.As a result of organic qualitative analysis of the foreign matter, cellulose was detected.As a result of elemental analysis of the foreign matter, large amount of carbon, iron, chrome and oxygen was contained and small amount of aluminum and silicon was contained.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Based on the results of investigation, omsc concluded that the foreign matter was mixture of cellulose, hydroxide and mineral (metal), however omsc could not determine what the foreign matter was.There was the possibility that the cellulose product had entered into the subject device from outside of the subject device, then hydroxide and metallic powder had adhered to the cellulose.Then during reprocessing the cellulose product might have moved from the reprocessing basin to the tank and adhered to water level sensor, consequently error e14 might have occurred by false detection.If additional information becomes available, this report will be supplemented.

• Brand Name: OLYMPUS ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12825144
• MDR Text Key: 283586730
• Report Number: 8010047-2021-14641
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1