MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2016-07-19 for PENTAX KH-2415S manufactured by Hoya Corporation Pentax Tokyo Office.
[50301574]
(b)(4). This mdr was initiated as part of a capa-driven remediation effort related to filing of mdrs for complaints/events outside of the us (ous). As part of this remediation, pentax medical performed a retrospective mdr assessment of all ous events/complaints received since october 2015. The retrospective assessment of this event prompted pentax medical to file this report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[50301575]
Pentax medical was made aware of a report for an event which occurred outside the usa stating "broken biopsy forceps handle. Hanger for thumb ring broken. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610877-2016-00145 |
| MDR Report Key | 5806290 |
| Report Source | FOREIGN |
| Date Received | 2016-07-19 |
| Date of Report | 2016-03-03 |
| Date Facility Aware | 2016-03-03 |
| Report Date | 2018-02-23 |
| Date Reported to FDA | 2018-02-23 |
| Date Reported to Mfgr | 2018-02-23 |
| Date Mfgr Received | 2016-03-03 |
| Device Manufacturer Date | 2014-12-05 |
| Date Added to Maude | 2016-07-19 |
| 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. MATTHEW VERNAK |
| 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 AKISHIMA-SHI |
| Manufacturer City | 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 | FORCEPS, SPIKE |
| Product Code | GCL |
| Date Received | 2016-07-19 |
| Model Number | KH-2415S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 15 MO |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Congenital Not Applicablenomaly | 2016-07-19 |