PENTAX KH-2415S

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number9610877-2016-00145
MDR Report Key5806290
Report SourceFOREIGN
Date Received2016-07-19
Date of Report2016-03-03
Date Facility Aware2016-03-03
Report Date2018-02-23
Date Reported to FDA2018-02-23
Date Reported to Mfgr2018-02-23
Date Mfgr Received2016-03-03
Device Manufacturer Date2014-12-05
Date Added to Maude2016-07-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. MATTHEW VERNAK
Manufacturer Street3 PARAGON DRIVE
Manufacturer CityMONTVALE NJ 07645
Manufacturer CountryUS
Manufacturer Postal07645
Manufacturer Phone8004315880
Manufacturer G1HOYA CORPORATION PENTAX TOKYO OFFICE
Manufacturer StreetTSUTSUJIGAOKA 1-1-110 AKISHIMA-SHI
Manufacturer CityTOKYO, 196-0012
Manufacturer CountryJA
Manufacturer Postal Code196-0012
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePENTAX
Generic NameFORCEPS, SPIKE
Product CodeGCL
Date Received2016-07-19
Model NumberKH-2415S
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age15 MO
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerHOYA CORPORATION PENTAX TOKYO OFFICE
Manufacturer AddressTSUTSUJIGAOKA 1-1-110 AKISHIMA-SHI TOKYO, 196-0012 JA 196-0012


Patients

Patient NumberTreatmentOutcomeDate
101. Congenital Not Applicablenomaly 2016-07-19

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