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

Model Number TT012

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.The lot/batch was not provided, therefore a manufacturing record evaluation could not be performed.Attempts were made to obtain the following additional information and the device and the following information was received: was the surgeon already working in a small incision as a routine part of the procedure? or did the surgeon only make a new small incision to retrieve the broken parts of the trocar sleeve? no further information is available.Did the surgeon inspect the trocar sleeve and retrieved parts of the trocar sleeve to determine that all parts of the trocar sleeve were retrieved from the patient (as the trocar sleeve is not radiopaque).No further information is available.Are all parts being sent back for analysis (so that it can be determined if all parts of trocar sleeve were retrieved)? yes, the broken parts that were retrieved were sent too.No further information will be provided.The device has not yet been returned.If the device is received at a later date, a supplemental medwatch will be sent.

Event Description

It was reported that during a thoracoscopic lobectomy, the device was broken off when using a forceps with it.The surgeon had operated a small incision, so he removed all pieces from it.The broken pieces were retrieved, and x-ray was taken to confirm that no pieces were left inside the patient.The surgeon commented there was a possibility that the surgeon handled the forceps forcibly since the patient was big.Another device was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Date sent: 5/11/2020.D4: batch # t4101n.Investigation summary the analysis results found that the tt012 instrument was received with the sleeve broken.One potential cause for the damage found may be the inadvertent application of excessive force or torquing during insertion into the abdominal cavity.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

• Type of Device: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9941629
• MDR Text Key: 197775376
• Report Number: 3005075853-2020-02076
• 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
• Report Date: 03/19/2020

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 Model Number: TT012
• Device Catalogue Number: TT012
• Device Lot Number: T4101N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Initial Date Manufacturer Received: 03/19/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 04/14/2020
• Supplement Dates FDA Received: 05/11/2020
• Patient Sequence Number: 1