MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-12-07 for PENTAX NCU-7000 manufactured by Hoya Corporation Pentax Tokyo Office.
[130479787]
Continued: hoya corporation pentax (b)(4) office, specification developer, (b)(4). Pentax video gastroscope model eg-3485k is not distributed in the usa, therefore the pma/510(k) number is not applicable.
Patient Sequence No: 1, Text Type: N, H10
[130479788]
Pentax medical became aware of a report on 08nov2018, which occurred in (b)(6), stating "scopepilot image failed and froze on the screen. Physician was advancing the endoscope and the scopepilot image did not move. This could have led to perforation of the bowel if the physician had not caught on to the frozen screen. " involving pentax medical scopepilot model ncu-7000, unknown serial number. Endoscope details not provided. No impact to patient was noted. Description of any actions taken: scopepilot system was put through a hard power reset during procedure the event is currently being investigated by pentax medical.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610877-2018-00604 |
| MDR Report Key | 8142740 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-12-07 |
| Date of Report | 2018-11-08 |
| Date of Event | 2018-11-08 |
| Date Facility Aware | 2018-11-08 |
| Date Mfgr Received | 2018-11-08 |
| Date Added to Maude | 2018-12-07 |
| 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. WILLIAM GOELLER (TEMPORARY) |
| Manufacturer Street | 3 PARAGON DRIVE |
| Manufacturer City | MONTVALE NJ 07645 |
| Manufacturer Country | US |
| Manufacturer Postal | 07645 |
| Manufacturer Phone | 8004315880 |
| Manufacturer G1 | HOYA CORPORATION PENTAX TOKYO OFFICE |
| Manufacturer Street | TSUTSUJIGAOKA 1-1-110 |
| Manufacturer City | AKISHIMA-SHI, TOKYO 196-0012 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 196-0012 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PENTAX |
| Generic Name | SCOPEPILOT VIDEO PROCESSOR |
| Product Code | PEA |
| Date Received | 2018-12-07 |
| Model Number | NCU-7000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOYA CORPORATION PENTAX TOKYO OFFICE |
| Manufacturer Address | TSUTSUJIGAOKA 1-1-110 AKISHIMA-SHI, TOKYO 196-0012 JA 196-0012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-07 |