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

Catalog Number D11LT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation of Vessels (2135); Blood Loss (2597); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: how were the torn blood vessels repaired? stitch or bovie how much blood loss (mls) occurred as a result of the blood vessels being torn? minimal unknown.

Event Description

It was reported that during an unknown procedure, the trocar provided in the flex tray was inserted in the patient.When the obturator was removed, it caused blood vessels to be torn.An individual trocar of the same product code, not part of a flex tray, was used to complete the procedure.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event, and is being considered not reportable.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: how were the torn blood vessels repaired? stitch or bovie.How much blood loss (mls) occurred as a result of the blood vessels being torn? minimal unknown.Did the patient require a transfusion? no.Was there any patient consequence or change in post-operative care as a result of the event? no.

Event Description

It was reported that during an unknown procedure, the trocar provided in the flex tray was inserted in the patient.When the obturator was removed, it caused blood vessels to be torn.An individual trocar of the same product code, not part of a flex tray, was used to complete the procedure.No additional patient consequences were reported.

• Brand Name: XCEL DILATING TIP TROCAR
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• 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: 5414441
• MDR Text Key: 38125856
• Report Number: 3005075853-2016-00807
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D11LT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1