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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO UNIVERSAL 65 LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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US SURGICAL PUERTO RICO ENDO UNIVERSAL 65 LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 173052
Device Problem Failure to Fire (2610)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/10/2020
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

According to the reporter, while being applied within the diaphragm during hernia procedure, the staples were unable to be fired normally from the device. It was also reported that the stapler did not work. Another device was used to complete the case. There was no patient injury.

 
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Brand NameENDO UNIVERSAL 65
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 Key10458649
MDR Text Key204509685
Report Number2647580-2020-02731
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeNL
PMA/PMN NumberK912097
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/15/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/27/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number173052
Device Catalogue Number173052
Device LOT NumberP6M0201AX
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/02/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/11/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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