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 08/27/2021

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed from the user that it was found the foreign object came out from an air/water/instrument channel connector of the subject device for connecting the connecting tube during the preparation for use.[details] -its shape of foreign object was like the hardened white adhesive -the foreign object came out from where inside the right side of an air/water/instrument channel connector of the subject device.There was no patient injury associated with this report.

Manufacturer Narrative

Olympus medical systems corp.(omsc) was received the foreign objects and checked and found followings; [investigation results] -the foreign objects of the subject device were translucent, thin, elongated solid, elastic substance.-there was no defect on the subject device other than the reported phenomenon.-it was reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.[cause] the foreign objects of the subject device were translucent, thin, elongated solid, elastic substance.As a result of organic qualitative analysis of foreign objects, it was found that they were silicon-based substances.After confirming the manufacturing process for investigate the cause, it was confirmed that some silicon-based sealants were used in the assembly work of the connector for connecting the connecting tube of the endoscope cleaning and disinfecting device and the internal unit.However, due to the structure of the product, it was confirmed that there was no possibility that the sealant will squeeze out or enter the liquid supply channel, and if there is any abnormality, it can be detected during the inspection of the assembly process.Therefore, it was not possible to identify where the foreign object came from.It was speculated from the above, omsc presumed there was the possibility this phenomenon was attributed to silicon-based foreign object has entered the liquid supply channel at some point including when it was in use.However, it could not be identified the cause of the reported phenomenon.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: 12770144
• MDR Text Key: 282956398
• Report Number: 8010047-2021-14263
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• 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: 09/02/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1