MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-12-11 for COLPOSCOPE OCS-500 manufactured by Olympus Medical Systems Corp..
[185076551]
The subject ocs-500 has not returned to olympus medical systems corp. (omsc) for evaluation yet. Omsc investigate the subject ocs-500 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
[185076552]
During the colposcopy with the ocs-500, the camera system including otv-s190, and erbe (non-olympus) diathermy unit, the user got burn (red mark) on her neck, through a necklace she was wearing. The user reported that the burn happened while the user was holding the subject osc-500. The local service engineer visited the hospital site and performed the safety test on both the light source (cll-v1) and the camera system including the otv-s190. They passed the safety test, with no earth leakage issues. There was no report of the injury other than above.
Patient Sequence No: 1, Text Type: D, B5
[185201337]
This is a supplemental report for mfr report #8010047-2019-04243. The subject ocs-500 was not returned to olympus medical systems corp. (omsc) for evaluation, because the subject ocs-500 was not returned to omsc. Based upon the information from the local service engineer, the subject device had no irregularity and defect. The subject device is used 220 to 350 mm away from a patient, consequently the subject device does not contact to the patient. Therefore omsc surmised that the subject device did not relate to the reported event. However the exact cause of the reported event could not be conclusively determined at this time.
Patient Sequence No: 1, Text Type: N, H10
[185201427]
This is a supplemental report for mfr report #8010047-2019-04243. The subject ocs-500 was not returned to olympus medical systems corp. (omsc) for evaluation. Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity. The exact cause of the reported event could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2019-04243 |
| MDR Report Key | 9449246 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-11 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-11-19 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2019-12-11 |
| 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 | COLPOSCOPE |
| Generic Name | COLPOSCOPE |
| Product Code | HEX |
| Date Received | 2019-12-11 |
| 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 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-12-11 |