ENDO CLINCH II 174317

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-05-11 for ENDO CLINCH II 174317 manufactured by Us Surgical Puerto Rico.

Event Text Entries

[108005181] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[108005182] According to the reporter, during a prostatectomy, the jaws of the device were broke and fell on the patient? S cavity. They were able to retrieve the broken pieces of the device from the patient. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5


[119673601] Additional info: evaluation summary: post market vigilance (pmv) led an evaluation of one device. One jaw of the device was broken after the fulcrum. A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture. Replication of the reported condition may occur when the device is exposed to a side force (leverage) that consequently breaks one side of the jaws. Another possibility is when the device is activated with too much force to the jaws and is used in a twisting motion resulting in breakage. The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[119673602]
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2647580-2018-02434
MDR Report Key7507048
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-05-11
Date of Report2018-09-06
Date of Event2018-05-02
Date Mfgr Received2018-08-20
Device Manufacturer Date2017-03-21
Date Added to Maude2018-05-11
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 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 CLINCH II
Generic NameFORCEPS, OBSTETRICAL
Product CodeHDA
Date Received2018-05-11
Returned To Mfg2018-06-06
Model Number174317
Catalog Number174317
Lot NumberP7C0674PX
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerUS SURGICAL PUERTO RICO
Manufacturer Address201 SABANETAS INDUSTRIAL PARK PONCE PR 007164401 US 007164401


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-11

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