MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. BLADELESS TROCAR 12MM

Catalog Number TB12LT

Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2017

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.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.Additional information: can you please clarify if there was any tissue damage as a result of the "greater force by damaging the diaphragm with leakage"? if yes, please provide further detail of the damage.No damage but the air in the abdomen was lost and visibility was difficult.The lot/batch # p4r096 provided was reviewed to verify the product code.Upon review, it was determined that the product code does not correlate to the batch/lot.The lot number correlates to a b5st device.Do you have the correct batch and/or lot number for the tb12lt device? that was the lot provided on the complaint submission form, it states that the surgery was delayed for hours.Can you please provide the exact number of hours (or minutes) the procedure was delayed.It took an hour and a half more because they had to change the trocars and look for the trocar membrane that fell into the patient's cavity.The following information was requested, but unavailable: was there any patient consequence as a result of the 1.5 hour delay in the procedure? just to confirm, was the trocar membrane a seal that fell out of the trocar and fell into the patient? was the trocar membrane (seal) ever located and retrieved from the patient (and will it be returned for analysis with rest of device)? was there any change to procedure or post-op patient care due to the "trocar membrane" falling into the patient?.

Event Description

It was reported that during a laparoscopic cholecystectomy procedure, a 12mm trocar is placed and placed in the epigastro.Through this they pass 5mm instruments with which there is no problem, but when passing the 10mm as the clamp with the clips for ligation of the cystic and the artery there is difficulty being necessary sometimes to make a greater force by damaging the diaphragm with leakage.Constant after that.Today after the passage of one of the ten mm clamps is evidenced important air leak when removing the clamp by the trocar.When evaluating it becomes evident within the cavity the complete diaphragm of the touch.It is removed without complications but creates a risk for the patient when falling into the cavity and making the procedure difficult with constant loss of the tire.Another like device was used to complete the procedure.There were no adverse consequences for the patient.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: was there any patient consequence as a result of the 1.5-hour delay in the procedure? not any, only the delay of the procedure just to confirm, was the trocar membrane a seal that fell out of the trocar and fell into the patient? yes, the membrane fell into the patient was the trocar membrane (seal) ever located and retrieved from the patient (and will it be returned for analysis with rest of device)? the trocar membrane was rescued, but this was not delivered by the institution as evidence was there any change to procedure or post-op patient care due to the "trocar membrane" falling into the patient? not.

• Brand Name: BLADELESS TROCAR 12MM
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 6604266
• MDR Text Key: 76512193
• Report Number: 3005075853-2017-02834
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TB12LT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2017
• Initial Date FDA Received: 06/01/2017
• Supplement Dates Manufacturer Received: 07/05/2017
• Supplement Dates FDA Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR