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

Model Number GF-UE160-AL5

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to omsc but was returned to olympus (b)(4 (b)(4) sent the device to a third party laboratory for microbiological testing.As a result of the testing, no microbe was detected from the sample collected from the all channels of the device.The testing result cleared the french guideline.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 that as a result of multiple microbiological testing by the user facility, following microbes were detected from the sample collected from the subject device.First time; (b)(6) 2021.All channels: klebsiella pneumoniae and pseudomonas aeruginosa (the total cfu of the klebseilla pneumoniae and pseudomonas aeruginosa is >100 cfu/100ml.) second time; (b)(6) 2021.All channels: klebsiella pneumoniae, pseudomonas aeruginosa and staphylococcus hominis (the total cfu of the klebsiella pneumoniae, pseudomonas aeruginosa and staphylococcus hominis is >100 cfu/100ml.).The device had been reprocessed with a non-olympus automated endoscope reprocessor, wd440 adaptascope (wassenburg), using peracetic acid.There was no report of infection associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus france (ofr) checked the subject device and found following; - there was leakage from the bending section rubber.- the ultrasonic transducer was slightly scratched and damaged.- the insertion tube was damaged and kinked.- the boot had damaged.- the control section had wear and tear.- the rubber of the remote switch 1 was pierced.- the universal cord and the ultrasonic cable were kinked.- the water supply connector was loose/rotatable.- the electrical connector was corroded.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.

• Brand Name: ULTRASONIC GASTROVIDEOSCOPE
• Type of Device: 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: 11331073
• MDR Text Key: 233366541
• Report Number: 8010047-2021-02672
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• PMA/PMN Number: K051541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-UE160-AL5
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1