MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-04-23 for CONNECTING TUBE MAJ-1500 manufactured by Olympus Medical Systems Corp..
[142725320]
The subject maj-1500 has not returned to olympus medical systems corp. (omsc) for evaluation yet. Omsc will investigate the subject maj-1500 to determine the cause of this phenomenon when omsc receives it. There were no further details provided. If significant additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[142725321]
The local field service engineer reported that the pin of the equipment side connector of the subject maj-1500 was broken. The user think that the above thing have effect on the reprocess of the endoscope after (b)(6). The user performed the unspecified endoscopic procedures for the following patients of the infections. (b)(6): 2 persons. Colon infection : 1 person. After that, the user performed the unspecified endoscopic procedures on another patient with the endoscope used for the infected patient. The user will conduct on infection test on the subject patient. There was no report of the patient injury other than above.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2019-01783 |
| MDR Report Key | 8538926 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-04-23 |
| Date of Report | 2019-06-11 |
| Date of Event | 2019-04-02 |
| Date Mfgr Received | 2019-05-15 |
| Date Added to Maude | 2019-04-23 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | CONNECTING TUBE |
| Generic Name | ENDOSCOPE REPROCESSOR ACCESSORIES |
| Product Code | FEB |
| Date Received | 2019-04-23 |
| Model Number | MAJ-1500 |
| 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 | 2019-04-23 |