MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-06 for ENDOSCOPIC CO7 REGULATION UNIT UCR manufactured by Olympus Medical Systems Corp..
[93807975]
The referenced ucr is not returned to olympus medical systems corp. (omsc) for evaluation, therefore omsc cannot evaluate the ucr yet. The exact cause of the reported event could not be conclusively determined at this time. However it is generally known that the perforation during endoscopy is attributed to handling by physician and/or patient? S condition. Therefore, there is the possibility of this phenomenon is attributed to the handling by the physician and/or the patient? S condition. Furthermore, because the bowel preparation of the patient had been insufficient, there was the possibility that the physician could not observe the endoscopic image clearly. Omsc stated the appropriate handling of the devices in the instruction manual of ucr. Omsc checked the manufacture history of the ucr, there was no irregularity found. 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
[93807976]
Olympus was informed that during the colonoscopy the physician found the bleeding of the patient? S bowel which was behind fecal matter. The bowel preparation of the patient had been insufficient. Because the perforation was suspected, the physician stopped the procedure and withdrew the endoscope from the patient. Subsequently the patient underwent the x-ray at bedside, then the physician confirmed the perforation. Consequently the patient underwent the hemicolectomy. The patient is recovering.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-01923 |
| MDR Report Key | 7085839 |
| Date Received | 2017-12-06 |
| Date of Report | 2018-03-19 |
| Date of Event | 2017-11-07 |
| Date Mfgr Received | 2018-02-26 |
| Date Added to Maude | 2017-12-06 |
| 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 |
| Brand Name | ENDOSCOPIC CO7 REGULATION UNIT |
| Generic Name | CO2 REGULATION UNIT |
| Product Code | FCX |
| Date Received | 2017-12-06 |
| Model Number | UCR |
| Device Availability | * |
| 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 | 2017-12-06 |