MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC GASTROVIDEOSCOPE

Model Number	GF-UC140P-AL5
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device in this report has not been returned to omsc for evaluation but was returned to olympus (b)(4) (oekg).The evaluation is in progress currently.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 or Problem Description
Olympus medical systems corp.(omsc) was informed that as a result of routine microbiological testing by the user facility, following microbes were detected from the sample collected from the subject device.Coagulase-negative staphylococci (>100 cfu/endoscope).The device had been reprocessed with a non-olympus automated endoscope reprocessor, wassenburg wd440 adaptascope, using peracetic acid.There was no report of infection associated with this report.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The subject device has not been returned to omsc but was returned to olympus france.(ofr).Ofr sent the device to a third-party laboratory for microbiological testing.As a result of the testing, the sample collected from the air/water channel of the device tested positive for the following.Instrument channel: unspecified bacteria (<1 cfu/endoscope); suction channel: unspecified bacteria (<1 cfu/endoscope); air/water channel: unspecified bacteria (<1 cfu/endoscope); auxiliary water channel: gram-positive bacteria (1 cfu/endoscope).The testing result cleared the french guideline.According to the evaluation, ofr found that the bending section rubber adhesive was peeled.The exact cause of the reported event could not be conclusively determined.Omsc surmised that this phenomenon attributed to the following.Omsc surmised that this phenomenon attributed to the following.The user handling of the device reprocessing was inappropriate.The device was contaminated occurred during the microbiological testing.If significant additional information is received, this report will be supplemented.

• Brand Name: ULTRASONIC GASTROVIDEOSCOPE
• Common Device Name: ULTRASONIC GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12306277
• Report Number: 8010047-2021-10077
• Device Sequence Number: 5002348
• Product Code: ODG
• UDI-Device Identifier: 04953170062803
• UDI-Public: 04953170062803
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K011314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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
• Operator of Device: Health Professional
• Device Model Number: GF-UC140P-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1