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

Catalog Number B12LT

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

Event Description

Duck seal damaged.During the endoscopic rectal cancer surgery, could not insert the obturator into the obturator sleeve.Checked the device, found the duck seal was not separated.Another device was used to complete the surgery.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Batch # r92e90.Device analysis: 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 the obturator was attempted to be introduced into the sleeve assembly however it could not be introduced due to a closed duckbill and torn.This condition is most likely related to the manufacturing process.The reported complaint was confirmed.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• 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: 7586888
• MDR Text Key: 110910605
• Report Number: 3005075853-2018-10476
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20705036001161
• UDI-Public: 20705036001161
• 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: 05/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: B12LT
• Device Lot Number: R4061H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Date Manufacturer Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1