MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*THORACIC TROCAR SLEEV

Catalog Number TT012

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.As a lot/batch was not provided, a device history could not be performed.

Event Description

It was reported that during a semi-open pneumonectomy, the tip of the outer sleeve was broken off during use.No pieces were left inside the patient.Another device was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4) batch # p9454r, p94197, p9404h.Device analysis: the analysis results found that the tt012 device was received with the cannula broken; the broken piece of the cannula was returned inside a plastic bag.In addition, the tyvek was returned along with the instrument.One possible cause for the damage found on the cannula, may be excessive external load placed on the device.The lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the packaging process.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.Performed by hugo serrano.

• Type of Device: THORACIC TROCAR
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7312802
• MDR Text Key: 101709866
• Report Number: 3005075853-2018-08326
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 20705036013379
• UDI-Public: 20705036013379
• Combination Product (y/n): N
• PMA/PMN Number: K920110
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: TT012
• Device Lot Number: P4T80R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Date Manufacturer Received: 03/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1