MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-02-12 for EVIS EXERAII BRONCHOVIDEOSCOPE UNKNOWN manufactured by Olympus Medical Systems Corp..
[188989650]
The subject device has not been returned to omsc but was returned to olympus europa (b)(4). (oekg). Oekg 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 distal end and instrument channel of the subject device. 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.
Patient Sequence No: 1, Text Type: N, H10
[188989651]
Olympus medical systems corp. (omsc) was informed that 36 patients were infected with mycobacterium lentiflavum. The facility owns olympus bronchovideoscope model bf-q180 (serial number: (b)(4), bf-uc180f (serial number: (b)(4), bf-1th190 (serial number: (b)(4) and bf-1t60 (serial number: (b)(4), and may have been used for these patients, but it is unknown which scope was used for which patient. The devices had been reprocessed with an olympus automated endoscope reprocessor model minietd2 (not available in the usa). Other detailed information such as the outcome of patients was not provided. Omsc is submitting 36 medical device reports according to the number of the infected patients. This is 33 of the 36 reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2020-01263 |
| MDR Report Key | 9698492 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-02-12 |
| Date of Report | 2020-03-06 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-02-12 |
| 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 KAZUTAKA MATSUMOTO |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVIS EXERAII BRONCHOVIDEOSCOPE |
| Generic Name | BRONCHOVIDEOSCOPE |
| Product Code | EOQ |
| Date Received | 2020-02-12 |
| Model Number | UNKNOWN |
| 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 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-12 |