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

Catalog Number B12LT

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unknown.Possible lot number: t4008h.Per photographic and video evaluation: upon visual inspection of one photo and a video, the following was observed: the photo shows a sleeve assembly from top view and appears to be the duckbill is closed.The video shows a sleeve assembly in the hand of user.At the 00:01 the user pushes the duckbill several time with a surgical instrument and appears to be closed.At the 00:10 mark the user try introduced the obturator into the sleeve assembly; however, it could not be introduced due to closed duckbill.Based on the photo and video the event describe is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.

Event Description

Seal issue.It was reported that during the endoscopic radical resection of right colon cancer surgery, b12lt was used to establish the abdominal cavity channel, found the first sealing film was integrated and the puncture insert could not pass through at all.Another device was used to complete the surgery.There were no adverse consequences to the patient.

• Brand Name: ENDOPATH XCEL BLADELESS TROCAR
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8700595
• MDR Text Key: 149130659
• Report Number: 3005075853-2019-19749
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001164
• UDI-Public: 10705036001164
• Combination Product (y/n): N
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B12LT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1