ENDO GRASP 173030

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-09-11 for ENDO GRASP 173030 manufactured by Us Surgical Puerto Rico.

Event Text Entries

[119930441] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[119930442] According to the reporter, during a laparoscopic myomectomy, when the doctor used the grasp to clamp the tissue, the sheet of the jaw was broken. They change the device to complete the case. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5


[130701768] Additional information: (udi), evaluation summary: post market vigilance (pmv) led an evaluation of one device. One jaw of the device was broken at the fulcrum. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition. 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. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[130701769]
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2647580-2018-04490
MDR Report Key7865625
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-09-11
Date of Report2018-12-07
Date of Event2018-08-21
Date Mfgr Received2018-11-14
Device Manufacturer Date2017-08-25
Date Added to Maude2018-09-11
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 GRASP
Generic NameFORCEPS, OBSTETRICAL
Product CodeHDA
Date Received2018-09-11
Returned To Mfg2018-08-22
Model Number173030
Catalog Number173030
Lot NumberP7H1885PX
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 2018-09-11

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