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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 Problems Physical Resistance (2578); Mechanical Jam (2983); Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/02/2017
Event Type  Malfunction  
Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, during the procedure, the device jammed, the handle would not squeeze and approximately five to six tacks were left in the product. Another device had to be opened.

 
Manufacturer Narrative

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

 
Event Description

According to the reporter, per additional information received there were tacks fired normally from the device before it jammed. There was no affect the patient due to the product problem.

 
Manufacturer Narrative

Evaluation summary: post market vigilance led an evaluation of one device. The visual inspection of the returned product noted a tack was protruding from the end of the shaft and the instrument timing disrupted. The handle was actuated and the remaining 7 tacks deployed but did not seat properly in the test media. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Replication of the disrupted timing and improperly seating tack is caused by an instrument that has been exposed to excessive force while applying helixes to a surface. If a helix is fired over improper surfaces it can provoke the exertion of excessive force to the handle causing the unit to disrupt the timing and to a possible jam. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate. If information is provided in the future, a supplemental report will be issued.

 
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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
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key6834953
MDR Text Key84249709
Report Number2647580-2017-06373
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK090470
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/16/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/31/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2020
Device MODEL Number174006
Device Catalogue Number174006
Device LOT NumberP5H0649X
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/31/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/26/2015
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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