MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-16 for ENDOSCOPE POSITION DETECTING UNIT UPD-3 manufactured by Olympus Medical Systems Corp..
[89366638]
The referenced upd-3 was not returned to olympus medical systems corp. (omsc) for evaluation, therefore omsc cannot evaluate the upd-3. The exact cause of this phenomenon cannot be conclusively determined, however there is the possibility of this phenomenon is attributed to inappropriate handling of the upd-3 by the facility. Omsc checked the manufacture history of the upd-3, 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
[89366639]
During the colonoscopy, when the receiver dish arm of the upd-3 was moved, the patient suffered the skin tear because the cable holder on the receiver dish stand contacted with the patient. The patient was treated and bandaged. The colonoscopy was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-01475 |
| MDR Report Key | 6950696 |
| Date Received | 2017-10-16 |
| Date of Report | 2017-10-16 |
| Date of Event | 2017-09-15 |
| Date Mfgr Received | 2017-09-19 |
| Device Manufacturer Date | 2012-05-29 |
| Date Added to Maude | 2017-10-16 |
| 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 |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOSCOPE POSITION DETECTING UNIT |
| Generic Name | ENDOSCOPE POSITION DETECTING UNIT |
| Product Code | ODA |
| Date Received | 2017-10-16 |
| Model Number | UPD-3 |
| 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 | 2017-10-16 |