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

Model Number OER-PRO

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/23/2020

Event Type  malfunction  

Manufacturer Narrative

Device has not been returned for evaluation.Based on the onsite evaluation, the field service engineer(fse) observed that the detergent pump, sensor, and tubing could be contributing factors, and these components were successfully replaced.Fse then observed that the basin's temperature probe was loosened and also could be a contributing source of the leak.Fse tightened down the temperature probe and informed the customer that possibly the fluid leaking from the machine was coming from the loosened temperature probe.While running a test cycle, the unit would not drain.After further investigation, the drain pump could not be activated.The device was placed out of use pending the drain pump order.The cause could not be determined.No further information was reported.

Event Description

The customer reported to olympus that a detergent leak was deriving from the endoscope reprocessor scope washer.The customer observed the foamy detergent had leaked in the front of the machine.There was no patient injury reported.

Manufacturer Narrative

The investigation has been completed.A device history record (dhr) did not find any defects or nonconformities.All records indicate that the device was manufactured in accordance with all applicable procedures.The cause of the event cannot be conclusively determined.Possible causes include: a detergent leakage that might have occurred due to a loose temperature sensor.It may have caused a malfunction of the drain pump, which led cleaning fluid to remain in the reprocessing basin, as the fluid was impossible to be drained.

• 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: 10049107
• MDR Text Key: 222564325
• Report Number: 8010047-2020-02664
• 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: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-PRO
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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