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U.S. Department of Health and Human Services

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

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ETHICON ENDO-SURGERY, LLC. XCEL DILATING TIP TROCAR 11MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
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.
 
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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 Key8184007
MDR Text Key130990637
Report Number3005075853-2018-15284
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier10705036001560
UDI-Public10705036001560
Combination Product (y/n)N
PMA/PMN Number
K032676
Number of Events Reported1
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 Date04/30/2023
Device Catalogue NumberD11LT
Device Lot NumberR40G3Y
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2019
Initial Date Manufacturer Received 12/03/2018
Initial Date FDA Received12/20/2018
Supplement Dates Manufacturer Received01/14/2019
Supplement Dates FDA Received01/31/2019
Patient Sequence Number1
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