MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. XCEL DILATING TIP TROCAR 12MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number D12LT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # n9260v.Per photographic evaluation: upon visual inspection of the pictures, a d12lt device and the packaging material can be observed.The reset button nor the blade can be observed on the provided photographs; therefore, no conclusion could be reached as to the cause of the reported incident as the device was not returned for analysis.Device analysis: in order to evaluate the reported incident, the instrument was functionally tested; when the reset button was pushed to the armed position it was noted that the button returned to the unarmed position and the shield remained locked preventing the exposure of the blade.No conclusion could be reached as to what may have caused the reported incident.The batch history record was reviewed and identified a reset button defect related to the reported incident were found.When this occurs, our quality system documents the necessary actions to ensure final product quality.In addition, no protocols or ncr related to the complaint, were found during the manufacturing process.The final quality release criteria were met before this batch was released for distribution.

Event Description

It was reported that during a laparoscopy, spring for blade of trocar is not active.There were no patient consequences.

• Brand Name: XCEL DILATING TIP TROCAR 12MM
• 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: 7171420
• MDR Text Key: 96725752
• Report Number: 3005075853-2018-07093
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20705036001574
• UDI-Public: 20705036001574
• Combination Product (y/n): N
• PMA/PMN Number: K032676
• 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
• Report Date: 11/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: D12LT
• Device Lot Number: P4RL5R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1