ENDO PADDLE RETRACT 173046

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-22 for ENDO PADDLE RETRACT 173046 manufactured by Us Surgical Puerto Rico.

Event Text Entries

[167592718] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[167592719] According to the reporter, pre-operatively, there were four devices, and each has ripped upon retracting into sheath. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


[184777196] Evaluation summary: post market vigilance (pmv) led an evaluation of one device. A visual inspection of the returned product noted that the devices had damaged fabric paddle covers. Exposed deformation of the shafts of the introducers was observed. A functional evaluation found that the paddles were difficult to fully close due to the damage of both the shafts and paddle covers. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Replication of damaged paddle retractor cover may occur when either the paddle retractor is retracted with the paddle in a partially open state; pushing the introducer forward over a paddle that is not fully closed may cause stretching and breakage of the introducer; or if the paddle retractor is subjected to excessive manipulation or used for leverage, these forces may cause the tearing of the cover/ cloth. The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition. No further actions have been deemed necessary at this time. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2647580-2019-05732
MDR Report Key9360480
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-22
Date of Report2019-11-22
Date Mfgr Received2019-11-05
Date Added to Maude2019-11-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLISA HERNANDEZ
Manufacturer Street60 MIDDLETOWN AVE
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034925563
Manufacturer G1US SURGICAL PUERTO RICO
Manufacturer Street201 SABANETAS INDUSTRIAL PARK
Manufacturer CityPONCE PR 007164401
Manufacturer CountryUS
Manufacturer Postal Code007164401
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENDO PADDLE RETRACT
Generic NameRETRACTOR
Product CodeGAD
Date Received2019-11-22
Model Number173046
Catalog Number173046
Device Expiration Date1999-01-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUS SURGICAL PUERTO RICO
Manufacturer Address201 SABANETAS INDUSTRIAL PARK PONCE PR 007164401 US 007164401


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-22

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