MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPE REPROCESSOR

Model Number OER-PRO

Device Problem Mechanical Jam (2983)

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

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

The evaluation of the device for this issue is done on site by the field service engineer (fse).Fse noted the issue of the jammed disinfectant drawer and observed the drawer rails to be bent and could not be realigned.The required parts were ordered and the fse went on site on (b)(6) 2021, to execute the repairs.Equipment was repaired and verified according to instructions; verified opening and shutting acecide drawer numerous times with no issues.Drawer was replaced.Software attributes verified.Log file reviewed with no issues.Electrical safety test was not required or performed because the covers were not removed.

Event Description

As reported for this event, the drawer for the disinfectant jammed and difficult to close.There is no patient involvement and no harm reported to any patient.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.The device history record review confirmed that device was shipped in accordance with specifications.It is likely that some massive impact was added to the drawer rails which caused deformation of the rails leading to the bottle tray being impossible to be installed.However, it cannot be conclusively specified as the cause of the event.The instructions for use includes the following statements: chapter 8.Troubleshooting and repair if any irregularity is detected during an inspection or if the device is clearly malfunctioning, do not use it.

• Brand Name: 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
• MDR Report Key: 11453789
• MDR Text Key: 244809633
• Report Number: 8010047-2021-03533
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/19/2021

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-PRO
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 05/06/2021
• Supplement Dates FDA Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1