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

Model Number OER-S

Device Problems Device Reprocessing Problem (1091); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the facility that one patient developed cystitis after the unspecified therapeutic procedure with non-olympus endoscope.The subject endoscope had been cleaned manually with unspecified dishwashing detergent, then the subject endoscope had been reprocessed with olympus automated endoscope reprocessor oer-s using olympus-designated alkaline detergent endoquick and olympus-designated peracetic acid disinfectant acecide before the procedure at the facility.The user facility considered that the cause of cystitis was insufficient cleaning of the endoscope using the oer-s.The patient has been administered antibiotics and is being followed up as outpatient.The user facility did not provide other detailed information.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Based upon the information from the user the reported phenomenon was attributed to the inappropriate reprocess in combination with the subject device and non-applicable endoscope.This is a matter of user usage and there are no adverse events regarding the subject device.Since it was used in a combination that is not applicable, the effectiveness of cleaning and disinfection could not be guaranteed.Furthermore as the additional information from the user, the user had not checked the effectiveness of the disinfectant solution appropriately.If additional information becomes available, this report will be supplemented.

Manufacturer Narrative

This mdr is being submitted as a result of a complaint retrospective review.Please see updates to a1 and d8.Correction to g2 to add the foreign country japan.Based on the legal manufacturer's final investigation and the following considerations, a root cause could not be determined.- the equipment was used in incompatible combinations.- dishwashing detergent was used for manual cleaning.- effective concentration of disinfectant was not properly confirmed.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: 10598665
• MDR Text Key: 208931013
• Report Number: 8010047-2020-06976
• 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: Other,Foreign
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OER-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 10/27/2020; 03/29/2022
• Supplement Dates FDA Received: 11/25/2020; 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2019
• 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
• Patient Outcome(s): Other