MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-01-17 for PENTAX DP-D2518 manufactured by Hoya Corporation Pentax Tokyo Office.
[133908357]
(b)(4). Pentax medical model dp-d2518 is not distributed in the usa, therefore the pma/510(k) number is not applicable. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[133908358]
Pentax medical became aware of a report which occurred in (b)(6) stating, "the endoscopic image became dirty during the peeling process due to esd [endoscopic submucosal dissection] in the stomach, and once the device [electro-surgical knife] was removed, the blade surface of the mucosectom had disappeared entirely" involving pentax medical electro-surgical knife model dp-d2518, serial number (b)(4). It was unknown whether a new product or another company's product, but the esd procedure is complete. No patient information was provided. Pentax medical (b)(6) is currently investigating this event. On (b)(6) 2018, a device history review was performed which confirmed the electro-surgical knife was manufactured under normal conditions, passed all required inspections, and was released accordingly. In addition, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610877-2019-00173 |
| MDR Report Key | 8258467 |
| Report Source | FOREIGN |
| Date Received | 2019-01-17 |
| Date of Report | 2018-12-18 |
| Date of Event | 2018-12-17 |
| Date Facility Aware | 2018-12-18 |
| Report Date | 2019-01-17 |
| Date Reported to FDA | 2019-01-17 |
| Date Reported to Mfgr | 2019-01-17 |
| Date Mfgr Received | 2018-12-18 |
| Device Manufacturer Date | 2017-03-10 |
| Date Added to Maude | 2019-01-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ELECTRONIC SURGICAL KNIFE |
| Product Code | KGE |
| Date Received | 2019-01-17 |
| Model Number | DP-D2518 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 21 MO |
| 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 | 2019-01-17 |