MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. XCEL DILATING TIP TROCAR 11MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number D11LT

Device Problem Insufficient Information (3190)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 11/25/2018

Event Type  Injury  

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 device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Additional information: the doctor had to convert the video surgery to conventional method.The patient stayed in intensive center care for the first 3 days, after that she went to the room and stayed 05 more days, and after that, she was discharged.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What was the anatomical position of the trocars that were used? was the patient insufflated first prior to the trocar being placed? was this the primary port where the iliac artery was damaged? what trocar entries were visualized using laparoscopy? what was the positioning of the patient when the trocar was placed? what proactive steps were taken by the surgeon to point the trocar away from important internal structures?.

Event Description

On the day of the procedure, after surgery the doctor contacted alleging that he had injured the right iliac artery and iliac vein left, as had never happened to him.Procedure: appendectomy.

Manufacturer Narrative

(b)(4).Batch # r9382y.Device analysis: the analysis results that a d11lt device was received with no damage in the external components.Device was received with all the components of the assembly.During the functional testing the devices bullets retracted permitting the exposure of the blade during the advancement through the skin test media and returned to safe position upon penetration; the bullets performed as intended without any anomalies noted.It could not be determined what may have caused the event reported.No conclusion could be reached as to what may have caused the reported incident.The reported complaint could not be confirmed.A manufacturing record evaluation was performed for the finished device r9382y batch number, and no non-conformances were identified.

• Brand Name: XCEL DILATING TIP TROCAR 11MM
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8184007
• MDR Text Key: 130990637
• Report Number: 3005075853-2018-15284
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001560
• UDI-Public: 10705036001560
• Combination Product (y/n): N
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

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 Expiration Date: 04/30/2023
• Device Catalogue Number: D11LT
• Device Lot Number: R40G3Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 01/14/2019
• Supplement Dates FDA Received: 01/31/2019
• Patient Sequence Number: 1