CRILE FCPS 6-1/4 CVD MIRROR 105141

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-04-05 for CRILE FCPS 6-1/4 CVD MIRROR 105141 manufactured by Integra York, Pa Inc..

Event Text Entries

[141495645] The device was not returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10


[141495646] Sus voluntary event report foi for manufacturers (mw5084508) received on 19mar2019 for product id 105141, crile fcps 6-1/4 cvd mirror with the following information: on (b)(6) 2019, a nurse reported that an approximately 5mm portion crile artery forceps (6 1/4) curved clamp tip (1 tip), was identified to be missing at the conclusion of an unspecified procedure. The device was in contact with the patient and no obvious, immediate injury was observed. It was reported that a surgical delay (several minutes) occurred to perform an intra-operative x-ray to identify any potentially retained metallic bodies and for removal of the broken portion of the instrument. No impact to the patient. The patient status after the procedure was stable and recovering from the surgery.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2523190-2019-00053
MDR Report Key8488004
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-04-05
Date of Report2019-03-19
Date of Event2019-02-25
Date Mfgr Received2019-04-12
Date Added to Maude2019-04-05
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 ContactUSER KIMBERLY SHELLY
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1INTEGRA YORK, PA INC.
Manufacturer Street589 DAVIES DRIVE
Manufacturer CityYORK PA 17402
Manufacturer CountryUS
Manufacturer Postal Code17402
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCRILE FCPS 6-1/4 CVD MIRROR
Generic NameN/A
Product CodeHRQ
Date Received2019-04-05
Returned To Mfg2019-04-09
Catalog Number105141
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA YORK, PA INC.
Manufacturer Address589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-05

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