MAUDE Adverse Event Report: ETHICON ENDO SURGERY, INC (CINCINNATI) LIGACLIP CLIP APPLIER

Catalog Number LX207

Device Problems Detachment Of Device Component (1104); Peeled/Delaminated (1454); Failure to Align (2522); Failure to Form Staple (2579)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The following information was requested, but unavailable: did the peeled handle coating actually puncture or "drill" the surgical gloves? or did the peeled handle coating just have the potential to puncture or "drill" the surgical gloves? was there an actual adverse consequence for the patient? if there was an actual adverse consequence, please describe in detail the adverse consequence that occurred.

Event Description

It was reported that during a myocardial revascularization - cardiac surgery in the dissection of the mammary artery procedure, the clipper is misaligned, forming a cross clip, detaching from the artery.The white handle is peeling.The surgical staff informed the clipper arrives from sterilization center with problem.Suture was used to repair.There were no adverse consequences for the patient.

Manufacturer Narrative

(b)(4).Date sent: 10/17/2017.The analysis results found that the lx207 device was received with the handle coating damaged and jaws were misaligned; therefore, the clips could not be loaded into the jaws.However, it could not be determined what may have caused this condition.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The batch history records were reviewed and certed by external manufacturing that the manufacturing criteria was met prior to the release of the equipment.

• Brand Name: LIGACLIP CLIP APPLIER
• Manufacturer (Section D): ETHICON ENDO SURGERY, INC (CINCINNATI); 4545 creek rd; cincinnati OH 45242 2803
• Manufacturer (Section G): POST SURGICAL MANUFACTURING; 25 plant ave; hauppauge NY 11788 3804
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 6649545
• MDR Text Key: 78129033
• Report Number: 1527736-2017-00016
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LX207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1