MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON (8886848700)LAPCLP LIGCLP APPL; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 8886848700

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Material Protrusion/Extrusion (2979)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/26/2015

Event Type  Injury  

Event Description

Procedure: lap assisted distal gastrectomy.According to the reporter: prior to the second clipping, the surgeon clipped into the left gastric artery of approximately 3mm.The surgeon could not remove the jaws from the blood vessel even when the handle was not being squeezed.Oozing was found from the blood vessels.The surgeon ligated to the central side from jaws and opened up the wound to 9cm.The device was released from the tissue by grasping the clip tightly and changing its position a little.One side of the black protruded part of the jaws seemed to be stuck on the jaws.When the jaws were not removed, the angle of clips were out of position.Operating time was extended by less than thirty minutes.No tissue damage and nothing fell into the cavity.Currently, the patient status is good.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Additional attempts to obtain information and the device have been made.A supplemental report will be submitted with new details if they become available.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.(b)(4).

• Brand Name: (8886848700)LAPCLP LIGCLP APPL
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4912586
• MDR Text Key: 6013503
• Report Number: 1219930-2015-00539
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K925602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8886848700
• Device Catalogue Number: 8886848700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other