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

Model Number OER-PRO

Device Problem Material Fragmentation (1261)

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

Event Date 02/28/2022

Event Type  malfunction  

Manufacturer Narrative

Following the customer's report, olympus dispatched a field service engineer (fse) to the facility.While at the facility, the fse repaired and verified the equipment according to the instructions.The subject device is now functioning properly.If additional information becomes available prior to the completion of the investigation, a supplemental report will be filed.

Event Description

The customer reported that her olympus endoscope preprocessor had a broken grey connector noted prior to reprocessing.There was no patient involvement during this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the gray connector could not be connected as some impact was added to the connector and the connector became loose and came apart.Probable causes for the event include: accumulated stress over time which caused the connector to get loose.Unintentional impact to the connector with something hard.We could not confirm any factor from the design nor structure of the device that would cause the reported event.The cause of the reported event cannot be conclusively determined.Per the instructions for use: ¿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.¿ and ¿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 device or facilities near the equipment.¿ olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13930330
• MDR Text Key: 297893060
• Report Number: 8010047-2022-05129
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/28/2022
• Supplement Dates Manufacturer Received: 04/13/2022
• Supplement Dates FDA Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2015
• 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