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

Model Number B12LT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # t9493e.A manufacturing record evaluation was performed for the finished device lot number and no non-conformance's were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that before an unknown procedure, the tip of the trocar sleeve had not opened so that the trocar and forceps could not insert though the sleeve.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 8/12/2020.D4: batch # t9493e.Investigation summary: the analysis results found that b12lt device was returned with no damage in the external components.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, attempted to introduce the obturator into the sleeve assembly, however, it could not be introduced due to a closed duckbill.This condition is most likely related to the manufacturing process.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• 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
• MDR Report Key: 10236041
• MDR Text Key: 198527004
• Report Number: 3005075853-2020-03371
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B12LT
• Device Catalogue Number: B12LT
• Device Lot Number: T40K69
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Date Manufacturer Received: 07/17/2020
• Patient Sequence Number: 1