MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-28 for PENTAX KB-D2416T manufactured by Hoya Corporation Pentax Tokyo Office.
[123806124]
(b)(4). Pentax model kb-d2416t is not distributed in the usa, therefore the pma/510(k) number is not applicable.
Patient Sequence No: 1, Text Type: N, H10
[123806125]
Pentax medical became aware of a report for an event which occurred in (b)(6) stating "during the (b)(6) (friday) examination, i could not seize the specimen. When pulled out from the endoscope was confirmed, the cup mechanism part was broken" involving pentax model kb-d2416t/lot 0180103. No adverse events were reported to have occurred with the patient or user. The device was returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610877-2018-00423 |
| MDR Report Key | 7919565 |
| Date Received | 2018-09-28 |
| Date of Report | 2018-09-03 |
| Date of Event | 2018-08-31 |
| Date Facility Aware | 2018-09-03 |
| Report Date | 2018-09-28 |
| Date Reported to FDA | 2018-09-28 |
| Date Reported to Mfgr | 2018-09-28 |
| Date Mfgr Received | 2018-09-03 |
| Date Added to Maude | 2018-09-28 |
| 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 | 0 |
| Brand Name | PENTAX |
| Generic Name | SINGLE USE FORCEPS WITH WINDOWS |
| Product Code | KGE |
| Date Received | 2018-09-28 |
| Returned To Mfg | 2018-09-05 |
| Model Number | KB-D2416T |
| Lot Number | 0180103 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-09-28 |