MAUDE Adverse Event Report: COVIDIEN ENDO CLIP LRGE 10MM PISTOL GRIP APPLIER; DISPOSABLE CLIP APPLIER

Catalog Number 176625

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976)

Patient Problem No Information (3190)

Event Date 03/04/2014

Event Type  Injury  

Event Description

Procedure type: laparoscopic cholecystectomy according to the reporter: closure of cystic arteria and cystic duct in laparoscopy procedure.Sudden evidence of biliar fistula, after 1 day from surgery.Four of the clips correctly applied during the surgery, on cystic duct, was found moved and opened.During the surgery, one clip was found to be closed not correctly, it was removed.The surgery took three hours time.The misformed clips were noticed immediately and removed laparoscopically.

Manufacturer Narrative

(b)(4).

• Brand Name: ENDO CLIP LRGE 10MM PISTOL GRIP APPLIER
• Type of Device: DISPOSABLE CLIP APPLIER
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; 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 avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3732953
• MDR Text Key: 4306924
• Report Number: 9612501-2014-00072
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K954435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 176625
• Device Lot Number: J2J0045X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2014
• Initial Date FDA Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other