MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-4 100V; ENDOSCOPE REPROCESSOR

Model Number OER-4

Device Problem Use of Device Problem (1670)

Patient Problems Nausea (1970); Complaint, Ill-Defined (2331)

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

The subject oer-4 did not return to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If significant additional information is received, this report will be supplemented.

Event Description

A user facility staff turned on power of the subject oer-4 and acecide (disinfectant solution) was leaked from the oer-4 during disinfectant solution heating process.The subject oer-4 stopped working due to display of e15 error.When a nurse checked the subject oer-4, he/she felt sick and became anorexia due to smell of acecide (disinfectant solution) leaked from the oer-4.The nurse recovered after about three hours of rest.There is no information that the nurse received medical treatment.The subject oer-4 was normal when a local service engineer checked it.The local service engineer assumed the cause of acecide (disinfectant solution) leak as the connecting tube that was caught between the reprocessing basin and lid of the subject oer-4 when the disinfectant heating process was started after the connecting tube was attached to the connector of the reprocessing basin of the subject oer-4.

Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2017-01887.It was impossible for olympus medical systems corp.(omsc) to perform evaluation of the subject oer-4 since the subject device was not returned to omsc.Omsc therefore reviewed the manufacturing record of the subject oer-4 to confirm that there were no abnormalities.According to the result of the inspection performed by the local service engineers, the subject oer-4 displayed the e15 error and acecide (disinfectant solution) was leaked out of the equipment due to a possible cause below: leakage of the acecide (disinfectant solution) out of the equipment was caused by the connecting tube that was caught between the reprocessing basin and a lid of the subject oer-4 when a user started the disinfectant heating process with the connecting tube attached to the connector of the reprocessing basin of the subject oer-4.This resulted in the decrease of the amount of the acecide.Omsc assumed that this phenomenon was caused not by failure of the subject device but by problems in use.If significant additional information is received, this report will be supplemented.

• Brand Name: OER-4 100V
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 7073861
• MDR Text Key: 94844638
• Report Number: 8010047-2017-01887
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

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
• Device Operator: Health Professional
• Device Model Number: OER-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2017
• Initial Date FDA Received: 11/30/2017
• Supplement Dates Manufacturer Received: 11/24/2017
• Supplement Dates FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2015
• 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