MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-11-21 for PENTAX H-S2518 manufactured by Hoya Corporation Pentax Tokyo Office.
[129327425]
(b)(4). Pentax model h-s2518 is not distributed in the usa, therefore the pma/510(k) number is not applicable.
Patient Sequence No: 1, Text Type: N, H10
[129327426]
Pentax medical became aware of an report, which occurred in (b)(6) stating "hemostasis was performed using pentax model h-s2518/serial (b)(4) to stop the bleeding site. It became hot enough that the sheath did not touch with the hand while energized. Therefore, pentax model h-s2518/serial (b)(4) was canceled and treatment was terminated using a new h-s2518. " no death or injury occurred to the patient or user. Pentax medical (b)(4) is currently investigating this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610877-2018-00528 |
| MDR Report Key | 8097112 |
| Report Source | FOREIGN |
| Date Received | 2018-11-21 |
| Date of Report | 2018-10-22 |
| Date of Event | 2018-10-16 |
| Date Facility Aware | 2018-10-22 |
| Report Date | 2018-11-21 |
| Date Reported to FDA | 2018-11-21 |
| Date Reported to Mfgr | 2018-11-21 |
| Date Mfgr Received | 2018-10-22 |
| Date Added to Maude | 2018-11-21 |
| 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 | 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 | HEMOSTASIS FORCEPS |
| Product Code | KGE |
| Date Received | 2018-11-21 |
| Model Number | H-S2518 |
| 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 | 2018-11-21 |