MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOSCOPE REPROCESSOR

Model Number OER-PRO

Device Problem Failure to Disinfect (1175)

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

Event Date 09/07/2022

Event Type  malfunction  

Manufacturer Narrative

In speaking with olympus technical support via the phone, the customer was advised the disinfectant had to be changed every five (5) days or roughly every thirty-five (35) cycles.The reporter was the infection control person at the facility.The reporter did not provide the cycle count and software version at the time of the call.The reporter was sent an updated email with a copy of olympus instruction for use (ifu) indicating if the acecide-c goes past five (5) days without being changed, results in non-conformance per the ifu.All scopes involved were reprocessed again according to ifu compliance.An olympus endoscopy support specialist (ess) has been dispatched to observe the user facility¿s reprocessing practices from start to finish and provide a reprocessing in-service training, if necessary, to correct and address any reprocessing deviations.The subject device referenced in this report was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus, the disinfectant in the oer-pro had gone past the five (5) day mark.The reporter stated the facility had performed twelve (12) reprocessing cycles that day.Twelve (12) scopes were reprocessed insufficiently or incorrectly.One cycle with two (2) evis exera ii colonovideoscopes had to be reprocessed a second time as the first time the lid was open and an e31 error message (open lid) was presented.The technician who performed the efficacy tests before each cycle had logged that all of scopes had passed the tests.Each scope except for the evis exera ii colonovideoscope had been used once on a patient.No patient injury or procedure impact reported.This complaint is related to patient identifiers: (b)(6) (gif-h180j / sn: (b)(4)), (b)(6) (gif-h180j / sn: (b)(4)), (b)(6) (gif-h180j / sn: (b)(4)), (b)(6) (cf-h180al / sn: (b)(4)), (b)(6) (cf-h180al / sn: (b)(4)), (b)(6) (cf-h180al / sn: (b)(4)), (b)(6) (pcf-q180al / sn: (b)(4)), (b)(6) (cf-h180al / sn: (b)(4)), (b)(6) (cf-180al / sn: (b)(4)), (b)(6) (gif-h180j / sn: (b)(4)), (b)(6) (cf-q180al / sn: (b)(4)), (b)(6) (pcf-h180al / sn: (b)(4)).

Manufacturer Narrative

This supplemental report is being submitted to provide a summary of the olympus endoscopy support specialist (ess) visit.An olympus endoscopy support specialist (ess) had been dispatched to observe the user facility¿s reprocessing practices from start to finish and provide a reprocessing in-service training, if necessary, to correct and address any reprocessing deviations.The olympus endoscopy support specialist (ess) noted that during the reprocessing in-service, no breaches were noted.The customer performed all the reprocessing steps according to the olympus instructions for use (ifu).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved 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, and since the device was not returned for evaluation, the definitive root cause of the disinfectant replacement issue could not be determined.It is possible that the issue occurred due to user error in management of the disinfectant solution and did not understand the period to replace acecide.The instruction manual identifies the following verbiage, which may have prevented the phenomenon:¿oer-pro operation manual 6.4 setting the disinfectant solution counter ·note on the disinfectant solution counter function.Acecide-c product overview ·reuse period up to 5 days.¿ olympus will continue to monitor field performance for this device.

• Brand Name: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15524609
• MDR Text Key: 306508376
• Report Number: 9610595-2022-02451
• 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,Followup
• Report Date: 01/05/2023

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: 09/08/2022
• Initial Date FDA Received: 10/01/2022
• Supplement Dates Manufacturer Received: 10/03/2022; 12/09/2022
• Supplement Dates FDA Received: 10/26/2022; 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2013
• 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