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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 Patient Involvement (2645)
Event Date 06/23/2020
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

According to the reporter, prior to use on a laparoscopic hernia repair procedure, straight out of packaging the device did not fire. A new device was used to complete the procedure. There was no patient involvement.

 
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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 Key10258230
MDR Text Key198346890
Report Number2647580-2020-02112
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
Type of Report Initial
Report Date 07/10/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/10/2020
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 NumberP9M1645Y
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/07/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/23/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/26/2019
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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