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

Catalog Number B12SRT

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event: unknown.Medical device: batch # r95245.Device analysis: the analysis results found that the b12srt device was returned with no damage in the external components.The device was visually inspected and no damaged was observed from the sealing components.The device was functionally tested to detect any mechanical issues.Upon evaluation of the device, no issues were noted related to a mechanical issues.No conclusion could be reached as to what may have caused the reported incident.The reported complaint could not be confirmed.A manufacturing record evaluation was performed for the finished device lot r41824 number, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch r95245 number, and no non-conformances were identified.

Event Description

It was reported that during an unknown procedure, the valve had a difficulty in closing (internal seal, valve inside of the trocar).Another device was used to complete the case.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: 8649284
• MDR Text Key: 146367583
• Report Number: 3005075853-2019-19376
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001188
• UDI-Public: 10705036001188
• 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: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: B12SRT
• Device Lot Number: R41824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2019
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1