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

Catalog Number D11LT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # n9167n.Additional information: no patient consequence reported.Procedure completed with same like device.Device analysis: the analysis results of the d11lt found that it was received with the reset button in disarmed position.In addition, the tyvek was returned along with the instrument.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.The obturator was disassembled in order to evaluate the condition of the internal components and no anomalies that could affect the functionality of the reset button were noted.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.The final quality release criteria were met before this batch was released for distribution.In addition, no protocols or ncr related to the complaint, were found during the manufacturing process.

Event Description

It was reported that during a procedure, the kit trocar did not activated the cutting blade.

• Brand Name: ENDOPATH XCEL
• 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: 6951082
• MDR Text Key: 89936518
• Report Number: 3005075853-2017-05475
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: D11LT
• Device Lot Number: N4LF82
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2016
• 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