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

Model Number OER-4

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); Swelling (2091)

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

The subject oer-4 was not returned to olympus medical systems corp.(omsc) for evaluation, therefore omsc cannot evaluate the subject oer-4.Omsc checked the device history record of the oer-4, there was no irregularity found.Omsc stated the appropriate handling of oer-4 and the counter measures against abnormalities in the instruction manual of oer-4.In the instruction manual of oer-4, the note is stated as the following.¿the front door cannot be closed unless the rubber cap is attached.¿ in the instruction manual of oer-4, the warning is stated as the following.¿when handling the disinfectant solution, wear appropriate personal protective equipment to prevent it from making direct contact with your skin and to prevent excessive inhalation of the vapor.¿ omsc judged the user did not wear personal protective equipment appropriately, based on information that the user touched acecide (disinfectant solution) with bare hands.Therefore, omsc concluded that this phenomenon is attributed to the inappropriate handling by the user.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

The person in charge (user a) removed the rubber cap to check the concentration of acecide (disinfectant solution) and forgot to put the rubber cap back on.After that, another person in charge (user b) noticed that the front door of the subject oer-4 was open, and attached the rubber cap.Then, user b touched acecide (disinfectant solution) leaked from the disinfectant removal port with bare hands.User b felt pain, and the skin at the back of right hand became swollen.After this event, omsc received information that the rubber cap was not broken.

• Brand Name: OER-4 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7657254
• MDR Text Key: 113393863
• Report Number: 8010047-2018-01264
• 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: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/03/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2017
• 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