MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. AUTOMATED ENDOSCOPE LEAK TESTER

Model Number	ALT-PRO
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation and the investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.This event has been submitted by the importer on mdr# 2951238-2021-00423.
Event or Problem Description
The customer reported to the olympus employee there is a patient infection following the use of an unknown scope.The customer states the automated endoscope leak tester did not detect a leak on the scope used with the patient.A request for additional information is in progress.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.New information was added to the following fields: the dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is unable to be determined.
Additional Manufacturer Narrative
Additional information was received from an olympus representative: the individual went into facility to investigate leak testing practices.Customer is following all leak testing guidelines and are performing leak testing appropriately.This false reading from the alt-pro leak tester came from faulty leak test connectors which since have been replaced.New leak tester connectors were tested and put into circulation.After following up with customer, there has not been a problem since.Therefore, the leakage likely occurred due to failure of the leak test connector; however, information on infection could not be obtained.

• Brand Name: AUTOMATED ENDOSCOPE LEAK TESTER
• Common Device Name: AUTOMATED ENDOSCOPE LEAK TESTER
• 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: 12562307
• Report Number: 8010047-2021-12578
• Device Sequence Number: 13839770
• Product Code: PCV
• UDI-Device Identifier: 04953170351761
• UDI-Public: 04953170351761
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K123704
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ALT-PRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 12/09/2021; 06/23/2022
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 01/07/2022; 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCOPE, MODEL UNKNOWN; SCOPE, MODEL UNKNOWN
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown