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

Model Number TT012

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Investigation summary the analysis results found that the tt012 instrument was received with the sleeve broken.Due to the damages found on the device, a possible cause for this condition is due to improper handling during transit or storage.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.In addition, a photo was received for review.Upon visual inspection of the photo, the following was observed: the photo shows an endopath thoracic device from front view and the device appears to be cracked near of the tip and extends over half of the device.Based on the photo, the event described is confirmed, however no conclusion or root cause could be determined.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.

Event Description

It was reported that during endoscopic lobectomy, opened the packing and noted the device was damaged.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.

• Type of Device: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10016978
• MDR Text Key: 194020772
• Report Number: 3005075853-2020-02454
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TT012
• Device Catalogue Number: TT012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Date Manufacturer Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1