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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO MULTIFIRE ENDO HERNIA LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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US SURGICAL PUERTO RICO MULTIFIRE ENDO HERNIA LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 174025
Device Problem Failure to Form Staple (2579)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/18/2020
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, during the closure of peritoneum on a laparoscopic right inguinal hernia repair, the staples did not form a proper b shape. Another device was used. There was no patient injury.

 
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Brand NameMULTIFIRE ENDO HERNIA
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
Manufacturer (Section G)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key10264086
MDR Text Key198521566
Report Number2647580-2020-02126
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK912097
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Remedial Action Recall
Type of Report Initial,Followup
Report Date 08/03/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/13/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number174025
Device Catalogue Number174025
Device LOT NumberP9J1171Y
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/30/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/25/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberR202003-06

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