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

Catalog Number B12LT

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign body, removal of (2365)

Event Date 03/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information: the analysis results found that the b12lt device was received with the cap of the sleeve assembly separated, causing its components to be out of position; the components from the sleeve were returned inside a bag, only the spring was not returned.In addition, the obturator cap was observed to be separated and the clear lens was noted to be fractured.The seal from the universal seal was in good condition.A potential cause of this condition is the repeated use of eto as a sterilization agent.Ees single-use trocars are not to be reused, reprocessed or re-sterilized.

Event Description

It was reported that during a low anterior resection procedure, the trocar was inserted, and then the robotic arm connected and the camera inserted through the trocar, the procedure started.After about 30 minutes, when retrieving the camera to be cleaned, the seal support of the trocar together with the trocar seal got dislodged.The body of the trocar remained in the patient wall.To continue the procedure the disconnected components of the trocar was fixed with sterile adhesive band in their initial place.The trocar was new.There was no patient consequence.

Manufacturer Narrative

(b)(4).No device received for analysis at time of submission of 3500a.When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.

• Brand Name: ENDOPATH BLADELESS 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 0096 9
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4670089
• MDR Text Key: 13144007
• Report Number: 3005075853-2015-02231
• Device Sequence Number: 1
• Product Code: GCJ
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2015

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 Expiration Date: 09/02/2019
• Device Catalogue Number: B12LT
• Device Lot Number: L4F912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/15/2015
• Initial Date FDA Received: 04/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1