MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2018-11-29 for SINGLE USE SPLINTING TUBE UNKNOWN (ST-SB1 OR ST-SB1S) manufactured by Olympus Medical Systems Corp..
[128720249]
The subject device has not been returned to olympus medical systems corp(omsc). Omsc could not review the service and manufacturing record because the lotl number was not provided from the facility. There was no malfunction report of the subject device concerning the events. The exact cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[128720250]
On (b)(6) 2018, olympus medical systems corp. (omsc) received a literature titled? Treatment result of endoscopic balloon dilation (ebd) for intestinal stenosis in crohn? S disease? That was made in public in 26th japan digestive disease week. The literature reported the results and accidental symptoms in 93 procedures of ebd, which was conducted at the user facility and affiliated facility, for 29 crohn disease patients. It was also reported that the 2 cases of accidental symptom (perforation) occurred in the ebd procedures and the perforations were treated with unspecified surgery. Omsc reviewed the delivery history of the endoscopes and the history revealed that olympus small intestinal videoscopes (model sif-h290s, sif-q260) and single use splinting tube (st-sb1, st-sb1s) had been delivered to the user facility. Omsc tried to obtain additional information from the user facility, but additional information was not provided at present. Since there was no information on the model of the small intestinal videoscope that was used in the 2 cases, omsc is submitting two mdrs according to the number of reported perforation cases in small intestinal videoscope and two mdrs in splinting tube. This is two of two reports in splinting tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-02316 |
| MDR Report Key | 8114262 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2018-11-29 |
| Date of Report | 2018-11-29 |
| Date Mfgr Received | 2018-11-01 |
| Date Added to Maude | 2018-11-29 |
| 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 | SINGLE USE SPLINTING TUBE |
| Generic Name | SINGLE USE SPLINTING TUBE |
| Product Code | FDA |
| Date Received | 2018-11-29 |
| Model Number | UNKNOWN (ST-SB1 OR ST-SB1S) |
| Lot Number | UNKNOWN |
| 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 | 2018-11-29 |