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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); Mechanics Altered (2984); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/25/2017
Event Type  Malfunction  
Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device. A visual inspection of the inner components of the instrument revealed that the timing was disrupted and a tack was protruding from the tip of the device. The trigger was actuated and the remaining sixteen tacks deployed but did not seat properly due to the disrupted timing. Replication of the reported condition 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. The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident. 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.

 
Event Description

According to the reporter: occurred during a laparoscopic hernia procedure. After several firings with the tacking device, the handle made a cracking sound and the surgeon could not squeeze it smoothly. The device was removed from the patient. The handle was squeezed to fire the device as a trial, then noted that a tack was slightly coming out of the tip of the device. Stopped using the device and the procedure was completed with another device. There was no patient harm.

 
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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 Key7195447
MDR Text Key97480914
Report Number2647580-2018-00311
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK090470
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial
Report Date 01/16/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/16/2018
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 NumberP7D0689PX
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/08/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/12/2017
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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