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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO ENDO CLIP LRGE 10MM PISTOL GRIP APPLIER; DISPOSABLE CLIP APPLIER
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COVIDIEN, FORMERLY USSC PUERTO RICO ENDO CLIP LRGE 10MM PISTOL GRIP APPLIER; DISPOSABLE CLIP APPLIER Back to Search Results
Catalog Number 176625
Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923)
Patient Problem Perforation (2001)
Event Date 02/05/2014
Event Type  Injury  
Event Description
Procedure: lap chole.According to the reporter: when the surgeon applied clips to the cystic duct all three of them slipped off and one perforated the duct.He had to use endoloops to tie off the duct.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
ENDO CLIP LRGE 10MM PISTOL GRIP APPLIER
Type of Device
DISPOSABLE CLIP APPLIER
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
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key3705394
MDR Text Key4266958
Report Number2647580-2014-00181
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K954435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2018
Device Catalogue Number176625
Device Lot NumberP3F0345X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received02/05/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/01/2013
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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