MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-3 100V; ENDOSCOPE REPROCESSOR

Model Number OER-3

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/09/2019

Event Type  malfunction  

Manufacturer Narrative

The subject oer-3 has not been returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

During reprocess with the subject oer-3, there was an abnormal noise that came from that subject device.When the user checked the subject device, the packing of the connector of the reprocessing basin was damaged.During there was an abnormal noise that came from the subject device, the user facility's endoscopes may have not been reprocessed sufficiently.The user is investigating the target patients and considering how to respond.There was no patient injury report related to the event.

Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2019 -03505.The subject connector of the subject oer-3 was returned to olympus medical systems corp.(omsc) for evaluation.When omsc checked the subject connector, the subject connector was following condition.The root of screw of connector was cracked.The appearance of the connector was discolored.Omsc reviewed the manufacturing history (dhr) of the subject oer-3 and confirmed no irregularity.Omsc could not investigate the cause of abnormal noise and packing deterioration because the subject oer-3 and the subject packing is not returned to omsc.Since the subject oer-3 and the subject packing was not returned, the exact cause was not determined; however, the following are potential cause.As ten years or more has passed since the manufacture date of the subject oer-3, omsc surmised that these phenomena occurred by aging degradation or other.The instruction manual of the oer-3 states the corresponding method in case of an abnormality.Important information - please read before use some problems that appear to be malfunctions may be corrected by referring to chapter 8, ¿troubleshooting and repair¿.If the problem cannot be resolved using the information in chapter 8, ¿troubleshooting and repair¿, contact olympus.Warning do not use the equipment if any connector seems to be damaged or defective.Using the equipment when an irregularity has been detected may interfere with reprocessing.Furthermore, fluid leakage may damage peripheral devices or facilities near the equipment.Inspection check the following for each connector.The connector should be fixed firmly.The o-rings should be free of abnormalities such as cracks, tears, or dents.

• Brand Name: OER-3 100V
• 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
• MDR Report Key: 9160494
• MDR Text Key: 207938127
• Report Number: 8010047-2019-03505
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• 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: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: OER-3
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1