MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-17 for EVIS EXERA DUODENOVIDEOSCOPE TJF-160VF manufactured by Olympus Medical Systems Corp..
[183874729]
The clinical endoscopy specialist was informed by the infection preventionist at the user facility, that the scope was involved with a patient who later tested positive for carbapenem-resistant enterobacteriaceae (cre). The patient's urine was cultured on (b)(6) 2020. The scope was cleaned and high level disinfected two times the scope has been reportedly used on other patients in between that time period. The infection preventionist could not release any patient(s) information and noted the scope was returned to be sterilized. A review of the scope's history indicates the asset scope was last serviced on june 5, 2018 (no problem found) and was last allocated on november 15, 2018. To date, there is no record of the scope being returned. As part of our investigation, an endoscopy support specialist (ess) was requested to be dispatched to the user facility to observe the facilities reprocessing practice and to provide a reprocessing training. To date, the ess visit has not been finalized as a results of cancelations and covid-19 issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2020-00380 |
| MDR Report Key | 9842971 |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-04 |
| Date Facility Aware | 2020-02-25 |
| Report Date | 2020-02-25 |
| Date Reported to Mfgr | 2020-02-25 |
| Date Added to Maude | 2020-03-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVIS EXERA DUODENOVIDEOSCOPE |
| Generic Name | DUODENOVIDEOSCOPE |
| Product Code | FDT |
| Date Received | 2020-03-17 |
| Model Number | TJF-160VF |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 14 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-17 |