MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-21 for OLYMPUS ENDOSCOPE UNKNOWN manufactured by Olympus Medical Systems Corp..
[80956345]
As part of our investigation, olympus made multiple follow-ups with the user facility by telephone and in writing in an attempt to gather more detailed information on the reported event, but only limited information was provided. The scope has not been returned to olympus for evaluation. The cause of the reported event could not be determined at this time. In addition, an olympus endoscopy support specialist (ess) was requested to be dispatched to the user facility to observe the facilities reprocessing practice and provide a reprocessing training. To date, the ess visit has not been finalized.
Patient Sequence No: 1, Text Type: N, H10
[80956346]
Olympus was informed that a total of six scopes (3 tjf-q180v and 3 unspecified scopes) and one olympus brush (bw-412t) culture have tested positive for bacillus. It was further reported that only one tjf-q180v (sn# (b)(4)) continues to test positive for bacillus and the other tjf scope cultures are now negative. There was no patient involvement with the scopes. This is 4 of 7 reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00469 |
| MDR Report Key | 6730945 |
| Date Received | 2017-07-21 |
| Date of Report | 2017-08-15 |
| Date of Event | 2017-06-27 |
| Date Mfgr Received | 2017-07-31 |
| Date Added to Maude | 2017-07-21 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OLYMPUS ENDOSCOPE |
| Generic Name | ENDOSCOPE |
| Product Code | GCM |
| Date Received | 2017-07-21 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-21 |