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-2422S manufactured by Hoya Corporation Pentax Tokyo Office.
[50182487]
(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
[50182488]
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 | 9610877-2016-00144 |
MDR Report Key | 5806307 |
Report Source | FOREIGN |
Date Received | 2016-07-19 |
Date of Report | 2016-03-04 |
Date of Event | 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 | 2014-09-09 |
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-2422S |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | 17 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 | 2016-07-19 |