MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-10-12 for ENDOSCOPIC CO7 REGULATION UNIT UCR manufactured by Olympus Medical Systems Corp..
[89345970]
The referenced ucr was not returned to olympus medical systems corp. (omsc) for evaluation. However the technician of the olympus (b)(4) evaluated the ucr and found that, though the ucr had the damage and discoloration which were unrelated to the function, the ucr operated without problem and the function of the insufflation was correct. The exact cause of the reported phenomenon cannot be conclusively determined, however, according to the literature, it is known that abdominal pain is common complication after colonoscopy due to residual air in intestinal tract. The air is emitted, and then the abdominal pain will be resolved. Therefore omsc concluded that this phenomenon was attributed to common complication of colonoscopy. Olympus stated the appropriate handling of the ucr in the instruction manual. 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
[89345971]
After the colonoscopy, the patient complained of severe abdominal pain. Other patient's injury and any medical intervention were not reported.
Patient Sequence No: 1, Text Type: D, B5
[113062538]
This is a supplemental report for mfr report #8010047-2017-99130 to correct section. As previously reported, both "disability or permanent damage" and "other serious (important medical events)" were checked. However it was correct that "other serious (important medical events)" only was checked.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2017-99130 |
| MDR Report Key | 6943324 |
| Report Source | USER FACILITY |
| Date Received | 2017-10-12 |
| Date of Report | 2017-10-12 |
| Date Mfgr Received | 2017-09-14 |
| Date Added to Maude | 2017-10-12 |
| 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 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| 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 | 2017-10-12 |
| Model Number | UCR |
| 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; 2. Deathisabilit | 2017-10-12 |