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.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Evaluation summary: post market vigilance (pmv) led an evaluation of one device opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, an engineering review of the product, and an evaluation of the returned device.The instrument was partially applied with eleven remaining clips.It was observed that the cartridge was disengaged form the body of the device.Due to the observed damage to the instrument, functional evaluation of the instrument could not be performed.During an engineering investigation, the cartridge was reattached to the body, with the c-clip inserted through the slot in the body nose and the knob in place.Once the trigger was cycled, the device loaded and properly formed some clips and then the knob and cartridge separated from the body instrument.Based on the evaluation findings, the root cause for the reported condition can be related to the c-clip being out of specification.Subsequently, the complaint data did display an increased trend for the reported condition.The instrument disengagement condition has been identified as a trend and a vendor notification has been initiated to prevent this condition from recurring.Should new information become available, the file will be re-opened and reassessed at that time.

• 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: 5377551
• MDR Text Key: 36317658
• Report Number: 9612501-2016-00030
• 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,Followup,Followup
• Report Date: 01/21/2016

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: 06/30/2020
• Device Model Number: 176657
• Device Catalogue Number: 176657
• Device Lot Number: J5F0565CX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other