MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT180

Device Problem Microbial Contamination of Device (2303)

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

Event Date 11/15/2021

Event Type  malfunction  

Manufacturer Narrative

The customer hmi (hygiene microbiological investigation) results reported device channel (all channels) tested positive with enterobacteries at >100 cfu, microorganism aerobies at >100 cfu, microorganism aerobies >100 cfu.The ofr (olympus (b)(4)) (b)(4) olympus subsidiary for hmi (hygiene microbiological investigation) results has not yet been received for evaluation.Below are information on customers cds checklist: pre-cleaner used during swabbing- ddn9.Ddn9/soluscope c -the detergent used for cleaning.Anioxyde 1000 - the disinfectant used for disinfection.Aer ¿ soluscope 4.Storage- stockage horizontal.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

As reported, after a microbiological routine control test on the subject medical device as required by (b)(6) regulation, the user detected an unexpected contamination.The issue found during reprocessing.The user then sent the device to the ofr (olympus (b)(4)) (b)(4) olympus subsidiary for hmi (hygiene microbiological investigation) for further investigation.The user did not report any contamination or any patient injury or patient infection to which this medical device could have been a contributory cause.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, device evaluation and olympus test results.A correction to g2 is being made.After the device was returned to olympus, it was sent out for additional testing.The microbiological analysis report indicated the channels of the scope were cultured and results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.The device was evaluated and the following defects were found: scope connector water mouthpiece was loose, bending section adhesive was chipped, suction cylinder was defective, stopper nut was defective, angulation wire has play.These defects were not considered severe enough to cause a potential adverse event and are likely due to wear and tear damage from use over an extended period of time.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more than 4 years since the subject device was manufactured.Based on the results of the investigation, it is unlikely the positive culture was caused by the device.Growth of microorganisms was found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with instructions for use (ifu) before repair, the results conformed to french recommendation.The following is included in the instructions for use (ifu): "reprocessing manual: 1.4 precautions: warning: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• 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: 13020748
• MDR Text Key: 287264867
• Report Number: 8010047-2021-16268
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

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: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2021
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2017
• 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