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

Model Number	D12XT
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Event or Problem Description
It was reported that during a prostatectomy procedure, the instructor noticed that the trocar blade did not retract as usual.It was locked and the surgeon decided to change the product and open another trocar.The moment the instrumentation encased the trocar in the cannula, the blade advanced and was unable to disarm it.At that moment, it was requested the exchange of the material, avoiding damage to the patient.The device had not been inserted into the patient.There was no damage to the patient or procedure.

• Brand Name: XCEL DILATING TIP TROCAR
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 9775405
• Report Number: 3005075853-2020-01354
• Device Sequence Number: 11490620
• Product Code: GCJ
• UDI-Device Identifier: 10705036001584
• UDI-Public: 10705036001584
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2020

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
• Operator of Device: Health Professional
• Device Model Number: D12XT
• Device Catalogue Number: D12XT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 03/02/2020
• Patient Sequence Number: 1