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 2017-11-08 for manufactured by Olympus Medical Systems Corp..
[91297871]
The subject device will not be returned to olympus medical system corp. (omsc) for investigation. Omsc has not finished the investigation yet. The exact cause could not be conclusively determined at this time. This report will be supplemented as soon as the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[91297876]
It was reported that there was perforation of four cases during colorectal endoscopic submucosal dissections. Olympus electrosurgical knife was used during each procedure. Perforation occurred during the procedure. They were all microscopic perforation and clip plications were possible to be performed. No cases needed emergency operation. There was no patient injury reported except the event. No further information was reported. Based on the reported information, there is a possibility that either kd-650 or kd-612 was used. This mdr is about the third of the four cases reported.
Patient Sequence No: 1, Text Type: D, B5
[113299306]
The subject device was not returned to olympus medical system corp. (omsc). Therefore, omsc could not evaluate the reported device. The exact cause of this issue could not be conclusively determined. Since the lot no. Is unknown, the manufacturing history record could not be reviewed. However, omsc has only shipped devices which passed the inspection. From the reported information, it is assumed that the event did not occur due to malfunction of the device, but occurred as a general accidental symptom of the procedure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2017-01683 |
| MDR Report Key | 7008668 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-08 |
| Date of Report | 2017-12-04 |
| Date Mfgr Received | 2017-11-13 |
| Date Added to Maude | 2017-11-08 |
| 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 KATSUAKI MORITA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO |
| Manufacturer Country | US |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | NWB |
| Date Received | 2017-11-08 |
| 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 | 2017-11-08 |