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U.S. Department of Health and Human Services

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

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US SURGICAL PUERTO RICO PROTACK LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 174006
Device Problem Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
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 fixation of mesh on a laparoscopic hernia surgery, the device got jammed while firing. Another device was used to complete the case. There was no patient injury.

 
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Brand NamePROTACK
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 Key10071563
MDR Text Key191452051
Report Number2647580-2020-01584
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberK090470
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 06/24/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/19/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number174006
Device Catalogue Number174006
Device LOT NumberP9E1010PY
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/20/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/07/2019
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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