MUELLER PHLEB HK RGHT SZ1 4-3/4 IN PHLEBECTOMY HOOK X21432

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-06-15 for MUELLER PHLEB HK RGHT SZ1 4-3/4 IN PHLEBECTOMY HOOK X21432 manufactured by Hebumedical Gmbh.

Event Text Entries

[77622616] The device was returned without the broken-off tip. Review of manufacturing records confirmed device conformance to specs at time of release. Hardness of returned device was tested and found conforming to specifications. Since the device was returned incomplete, i. E. , without the broken-off tip, it is not possible to reach a definite conclusion with regard to the cause of the fracture. However, this type of hook has a very delicate tip ranging from 0. 5mm to 1. 0mm in width due to the natural anatomical requirements of the vein-stripping procedure, and the tip may fracture if excessive pressure is applied by the surgeon. Thus the device most likely was not used in accordance with recognized best practices. A review of complaint history for this device for the last three years revealed no similar cases.
Patient Sequence No: 1, Text Type: N, H10


[77622617] Customer reports device tip broke off during a vein ligation and stripping on left leg. Tip retrieved, no patient harm. Device #3 of 3 used during same procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611112-2017-00004
MDR Report Key6642643
Report SourceOTHER
Date Received2017-06-15
Date of Report2017-06-15
Date of Event2017-04-07
Date Mfgr Received2017-05-16
Device Manufacturer Date2017-01-01
Date Added to Maude2017-06-15
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. THOMAS BUTSCH
Manufacturer StreetBADSTRASSE 8
Manufacturer CityTUTTLINGEN, 78532
Manufacturer CountryGM
Manufacturer Postal78532
Manufacturer Phone46194710
Manufacturer G1HEBUMEDICAL GMBH
Manufacturer StreetBADSTRASSE 8
Manufacturer CityTUTTLINGEN, 78532
Manufacturer CountryGM
Manufacturer Postal Code78532
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMUELLER PHLEB HK RGHT SZ1 4-3/4 IN PHLEBECTOMY HOOK
Generic NamePHLEBECTOMY HOOK
Product CodeGAI
Date Received2017-06-15
Returned To Mfg2017-05-23
Catalog NumberX21432
Lot Number31021706
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerHEBUMEDICAL GMBH
Manufacturer AddressBADSTRASSE 8 TUTTLINGEN, 78532 GM 78532


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-06-15

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