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

Model Number	ALT-PRO
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
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.

• 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
• MDR Report Key: 12562285
• Report Number: 2951238-2021-00423
• Device Sequence Number: 924142
• Product Code: PCV
• UDI-Device Identifier: 04953170351761
• UDI-Public: 04953170351761
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2021
• Report Date (Section F): 09/02/2021

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other