MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*THORACIC TROCAR SLEEV; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number TT012

Device Problems Delivered as Unsterile Product (1421); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that prior the endoscopic lobectomy procedure, the tt012 had damaged packaging that compromised the device sterility ("the device sterility is damaged").There were no patient consequence.

Manufacturer Narrative

(b)(4).Date sent: 8/5/2020.Additional information: a photo was received for review.Upon visual inspection of photo, the following was observed.The photo shows two tyvek wrappers from top view and the first tyvek wrapper of product code tt012 presents with a yellow stain.The second tyvek wrapper shows no damage noted.Based on the photo alone, the event described of packaging stain is confirmed, however no conclusion or root cause could be determined.Please refer to the device analysis for full analysis details and conclusion once device has been analyzed.

Manufacturer Narrative

(b)(4).Date sent: 8/26/2020.Investigation summary the analysis results found that the tt012 device was returned with no apparent damage.In addition, the tyvek was returned along with the instrument.Upon visual inspection, it appears to have a yellow stain on the tyvek, however, no damage was noted.No conclusion could be reached on what caused the tyvek to become stained.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure that the device meets the required specifications prior to shipment.

• Type of Device: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10347076
• MDR Text Key: 201369436
• Report Number: 3005075853-2020-03912
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10705036013372
• UDI-Public: 10705036013372
• 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,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: TT012
• Device Catalogue Number: TT012
• Device Lot Number: T40W6P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: 07/07/2020; 07/29/2020
• Supplement Dates FDA Received: 08/05/2020; 08/26/2020
• Patient Sequence Number: 1