• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

US SURGICAL PUERTO RICO MULTIFIRE VERSATACK LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 174021
Device Problem Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/22/2019
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 a procedure, the device jammed upon firing. There was no patient injury.

 
Manufacturer Narrative

Investigation summary: post market vigilance (pmv) led an evaluation of one device. The e-piece was partially disengaged from the device on one side. There was evidence of weld on the device. The loading unit was received preloaded on the instrument with three tacks remaining. The instrument was applied to the appropriate test media. The remaining three tacks deployed improperly and did not seat properly due to the disengaged e-piece. 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 reported condition may occur as a result of excessive manipulation of the device. The root cause of the observed damage was due to the product not being used as intended which caused or contributed to the reported condition. No further actions have been deemed necessary at this time. If information is provided in the future, a supplemental report will be issued.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9684062
MDR Text Key178261022
Report Number2647580-2020-00524
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK912097
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation RISK MANAGER
Type of Report Initial,Followup
Report Date 03/06/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/07/2020
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 NumberP8A1073X
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/14/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2020
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-