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

MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICOPROTACK 5MM INSTRUMENTDISPOSABLE STAPLER INSTRUMENT

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

COVIDIEN, FORMERLY USSC PUERTO RICO PROTACK 5MM INSTRUMENT DISPOSABLE STAPLER INSTRUMENT   Back to Search Results
Catalog Number 174006
Event Type  Injury   Patient Outcome  Other
Event Description

According to the reporter: several physiomesh were fixed with the product (non resorbable tacks) on the abdominal wall. It was difficult to fixate the mesh. The meshes have separated themselves over the tacks at about 5-6 patients which has lead to an additional corrective surgery for these patients. The tacks were still fixed at the abdominal wall. The tacks are continuously stressed due to the structure of the mesh. The mesh is very stiff and therefore does not suit very well on the abdominal wall. The mesh needs more time to be incorporated into the abdominal wall compared to our meshes which strains our tacks longer.

 
Manufacturer Narrative

(b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROTACK 5MM INSTRUMENT
Type of DeviceDISPOSABLE STAPLER INSTRUMENT
Manufacturer (Section F)
COVIDIEN, FORMERLY USSC PUERTO RICO
building 911-67
ponce PR 00731
Manufacturer (Section D)
COVIDIEN, FORMERLY USSC PUERTO RICO
building 911-67
ponce PR 00731
Manufacturer (Section G)
COVIDIEN, FORMERLY USSC PUERTO RICO
building 911-67
sabanetas industrial park
ponce PR 00731
Manufacturer Contact
melissa zaffin
60 middletown ave
north haven , CT 06473
(203) 492 -7141
Device Event Key2615126
MDR Report Key2585179
Event Key2481872
Report Number2647580-2012-00342
Device Sequence Number1
Product CodeOCW
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Physician
Type of Report Initial
Report Date 04/19/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/18/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number174006
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received04/19/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

-
-