MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP CLIP APPLIER; CLIP, IMPLANTABLE

Catalog Number ER420

Device Problems Migration or Expulsion of Device (1395); Failure to Form Staple (2579)

Patient Problems Bleeding (1738); Surgical procedure, additional (2564)

Event Date 01/05/2015

Event Type  Injury  

Event Description

It was reported that during a laparoscopic nephrectomy procedure, the surgeon used the device to clip the renal artery prior to transection placing 1 clip on the specimen side and two clips on the patient side and successfully transected.The patient was transported to recovery in good condition had a meal and later that evening coded and was told coded again in icu and the decision was made to open the patient and the surgeon could not find the 3 clips he placed on the renal artery.The bleeding was controlled and the patient is in icu but has not woken from the emergency procedure.This is all the details provided at this time by the surgeon and facility.The patient had to have an emergency procedure to control the bleeding hours after post-op.No device will be returned.

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.At the time of this submission, the device has not been returned for analysis.The following information was requested, but unavailable: is it routine for the surgeon to use an er420 clip on the renal artery? what was the approximate size of the artery? are there any photos or videos available for ethicon to review? were there any issues noted with clip formation during the initial procedure?.

Manufacturer Narrative

(b)(4).Additional information: physical device was not returned; x-ray images were provided and reviewed.Clips can be seen in some of the x-rays between (b)(6), yet in some x-rays, they are very faint or not visible due to the lack of contrast in the image.The formed clips appear to have no formation anomalies.Based on the photographic evidence there is confirmation that clips are present, but, unfortunately, there is insufficient evidence as to what may have caused the complaint issue.

• Brand Name: LIGACLIP CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4432472
• MDR Text Key: 5375909
• Report Number: 3005075853-2015-00503
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: ER420
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2015
• Initial Date FDA Received: 01/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention