MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study,use report with the FDA on 2018-12-26 for ST-CB1 manufactured by Olympus Medical Systems Corp..
[131375422]
The subject device has not been returned to olympus medical systems corp (omsc). Omsc could not review the service and manufacturing record because the serial number was not provided from the facility. 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
[131375423]
Olympus medical systems corp. (omsc) was informed that one day after an endoscopic submucosa dissection (esd) procedure on the ascending colon using olympus splinting tube model st-cb1, olympus colonovideoscope model pcf-h290zl, and pcf-h290tl, a perforation was found in the sigmoid colon of the patient during a follow up examination for the abdominal pain acompanied with a fever. The user facility performed an open abdominal surgery and repaired the perforation. It had been reported that the esd procedure was successfully completed and there was neither device malfunction nor patient? S complaint of pain. Omsc submits three medical device report on the three devices that may have been involved in the perforation. This is the first report out of a total of three.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-02562 |
| MDR Report Key | 8195282 |
| Report Source | HEALTH PROFESSIONAL,STUDY,USE |
| Date Received | 2018-12-26 |
| Date of Report | 2018-12-26 |
| Date of Event | 2018-12-04 |
| Date Mfgr Received | 2018-12-05 |
| Date Added to Maude | 2018-12-26 |
| 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 | ST-CB1 |
| Generic Name | SINGLE USE SPLINTING TUBE |
| Product Code | FDA |
| Date Received | 2018-12-26 |
| Model Number | ST-CB1 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-12-26 |