MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,foreign,user facility report with the FDA on 2014-11-11 for OLYMPUS MAH-2010 manufactured by Olympus Medical Systems Corporation.
[4991355]
Olympus was informed that during colonoscopy, when the physician inserted the colonoscope, though the subject device attached to the scope was not being operated, the patient's sigmoid colon swelled. The facility was aware that the subject device was improperly attached to the colonoscope. Olympus was informed that the patient complained about pain when a sigmoid colon swelled, however there was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[12495277]
Four pieces of maj-2010 including the subject device used in the user facility were returned to manufacturer for evaluation. As the result of the evaluation, it was revealed that there were no damage of deformation observed with all four units, and that there was no irregularity found. One of the returned devices were attached to a colonoscope of the same model as used in the reported event to test aspiration of co2 gas. As the result, it was confirmed that the reported phenomenon reproduced when the subject device was improperly attached. Based on the above, it could not be ruled out as a contributory factor to the event, that the subject device was improperly attached to the colonoscope.
Patient Sequence No: 1, Text Type: N, H10
[34310326]
Olympus medical systems corp. (omsc) performed mdr retrospective review and omsc found that this supplemental report is required on december 2, 2015.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2014-00695 |
| MDR Report Key | 4259147 |
| Report Source | 01,06,FOREIGN,USER FACILITY |
| Date Received | 2014-11-11 |
| Date of Report | 2015-12-24 |
| Date of Event | 2014-10-14 |
| Date Mfgr Received | 2014-10-14 |
| Date Added to Maude | 2014-11-21 |
| 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 | HIROKI MORIYAMA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 26425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | GAS/WATER VALVE |
| Product Code | FCX |
| Date Received | 2014-11-11 |
| Returned To Mfg | 2014-10-22 |
| Model Number | MAH-2010 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-11 |