MAUDE Adverse Event Report: COVIDIEN ENDO CLIP* II MED/LRG 10MM PISTOL GRIP; CLIP, IMPLANTABLE

Model Number 176657

Device Problems Failure To Adhere Or Bond (1031); Unintended Ejection (1234); Difficult to Advance (2920)

Patient Problems Fistula (1862); Tissue Damage (2104); Blood Loss (2597); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 12/02/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter: during a cholecystectomy procedure, bleeding was noticed on the cystic artery.The hemostasis could not be done.The clips of the device could not come out and could not close.Two clips were used and both fell on the cystic duct.The surgery time was extended and the tissue was damaged.After the procedure a biliary fistula was noticed.Additional information has been requested but not yet received.A supplemental will be submitted upon receipt of any new information.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5377602
• MDR Text Key: 36317210
• Report Number: 9612501-2016-00031
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K954435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 176657
• Device Catalogue Number: 176657
• Device Lot Number: J5H1784CX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 60