MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-MINI; ENDOSCOPE REPROCESSOR

Model Number OER-MINI

Device Problem Filtration Problem (2941)

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

Event Date 05/26/2021

Event Type  malfunction  

Manufacturer Narrative

As part our investigation, the technical assistance center (tac) assisted the customer with troubleshooting.Tac instructed the customer to try another test strip and reported back the same result.Referencing the ifu and the video from endowise, tac walked the customer step-by-step through the process of replacing the lcg.This time the process completed was without error.The customer tested the test strip again and this time it passed.The customer was unaware of what done differently prior to calling tac but the system is fine.The customer also reported an automatic cycle stop, after a minute without error.The customer started another cycle after the lcg was replaced and there was no issue observed.Tac reported that it appears that the customer must have put disinfectant into the basin at the wrong time causing it to be discarded down the drain and not to the disinfectant tank.Tac resolved the customer¿s issue over the phone and no field service engineer (fse) was dispatched to the customer¿s site.

Event Description

The service center was informed that the customer performed the "replace lcg" process and the process was completed without error.The customer reported that when the lcg was tested, the test strip remained white indicating the efficacy test failed.There was no patient infection, positive culture or patient involvement reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the lm investigation.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The lm reports that the root cause could not be identified.The legal manufacturer provided the following possible cause for the reported event are presumed as follows: improper usage of disinfectant at user facility was thought to be a cause of the event.The legal manufacturer judged that the equipment had no defect.The event was due to user¿s misuse.The user can prevent the event by handling the equipment in accordance with the following ifu statement.Disinfectant would be correctly replaced by performing the replacing step mentioned in 7.12 replacing the disinfectant solution.The manufacturer business center (mbc) confirmed via dhr that the equipment was shipped out, satisfying shipping specifications.

• Brand Name: OER-MINI
• 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: 12016743
• MDR Text Key: 256722205
• Report Number: 8010047-2021-07655
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/07/2021

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-MINI
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/17/2021
• Supplement Dates Manufacturer Received: 07/06/2021
• Supplement Dates FDA Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1