MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-02-15 for COLPOSCOPE OCS-500 manufactured by Olympus Medical Systems Corp..
[136279349]
The subject ocs-500 does not return to olympus medical systems corp. (omsc). The local engineer checked the subject ocs-500. There was no abnormality of the mechanical function when the zoom microscope body was connected to the balance arm. 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
[136279350]
During the unspecified colposcopy with the ocs-500, the zoom microscope body and the arm of the subject ocs-500 were detached and landed on the knee of the nurse before falling onto the floor. The knee of the nurse was hurt. The lens on the zoom microscope body smashed. The patient was a little shaken up as the procedure was stopped while the user cleaned up the glass on the floor and found the unspecified similar device to continue the procedure. There was no report of the patient? S injury other than above.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2019-01092 |
| MDR Report Key | 8342485 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-15 |
| Date of Report | 2019-04-17 |
| Date of Event | 2019-01-21 |
| Date Mfgr Received | 2019-04-02 |
| Date Added to Maude | 2019-02-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | COLPOSCOPE |
| Generic Name | COLPOSCOPE |
| Product Code | HEX |
| Date Received | 2019-02-15 |
| Model Number | OCS-500 |
| 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 | 1. Other | 2019-02-15 |