MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-17 for FUJINON manufactured by .
[75613337]
On april 11, 2017, the (b)(4) clinical specialist who observed the customer's reprocessing issues conducted an in service on endoscope manual cleaning and high level disinfection, as well as automated high level disinfection using the medivators dsd-201 model machine.
Patient Sequence No: 1, Text Type: N, H10
[75613338]
During a recent site visit, an (b)(4) clinical specialist observed various inconsistencies with customer adherence to manufacturers' reprocessing recommendations including lack of enzymatic detergent during pre-cleaning, failure to completely immerse endoscopes in detergent, brushing channels only once, incomplete immersion of scopes in rinse water and failure to inject water in channels post detergent exposure. Plus, use of incorrect medivators channel adapters during reprocessing of scopes in dsd aer. There were no reported patient injuries or allegations of product problems against fujifilm endoscopes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2431293-2017-00050 |
| MDR Report Key | 6573323 |
| Date Received | 2017-05-17 |
| Date of Report | 2017-05-17 |
| Date of Event | 2017-04-11 |
| Date Mfgr Received | 2017-04-11 |
| Date Added to Maude | 2017-05-17 |
| 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 |
| Manufacturer Contact | MR. JOHN BRZEZINSKI |
| Manufacturer Street | 10 HIGH POINT DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9736862430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FUJINON |
| Generic Name | ENDOSCOPE |
| Product Code | GCQ |
| Date Received | 2017-05-17 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-17 |