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U.S. Department of Health and Human Services

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

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US SURGICAL PUERTO RICO MULTIFIRE VERSATACK LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 174021
Device Problem Failure to Fire (2610)
Patient Problem No Information (3190)
Event Date 03/05/2020
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 promontofixation by laparotomy procedure, the surgeon used a first clamp that worked perfectly, and asked for a second to finish fixing his plate. However this second clamp did not deliver a staple, the device was blocked and no staple came out or would not deliver a clip when the surgeon actuated it. The surgeon then used another device to resolve the issue in order to complete the case. There was no patient injury.

 
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Brand NameMULTIFIRE VERSATACK
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 Key10316511
MDR Text Key200187004
Report Number2647580-2020-02289
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeFR
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 10/29/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/23/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number174021
Device Catalogue Number174021
Device LOT NumberP7G1532X
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/04/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/28/2020
Was Device Evaluated By Manufacturer? No
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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