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

Catalog Number	TT012
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 7/10/2024.D4: batch # unk.Additional information was requested and the following was obtained: "is the current patient status known? patient is recovering as normal.Was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.) there was no change in surgical plan or post operative management of the patient." investigation summary the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the tt012 device was received with the sleeve broken.In addition a piece of plastic from the sleeve was returned inside of a plastic bag.No conclusion could be reached regarding what may have caused the reported incident.One possible cause for the damage found may be due to excessive force being applied to the device.Please refer to the instructions for use for additional information regarding proper device usage.The manufacturing records couldn't be reviewed as the batch number is unknown.
Event or Problem Description
It was reported that during a vats right lower lobectomy, trocar was cracked after viewing it inside the patients thoracic cavity via the laparoscopic camera.Through out the surgery this trocar was removed and reinserted numerous times.Did not notice any cracking during this period.Therefore, they stated that the cracking had to had occurred near the end of the procedure, they do not recall a singular event occurring where the cracking could have taken place.The trocar was removed from the patient and removed from the field and visualization was done to ensure no remaining fragments were retained in the patient.

• Common Device Name: 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 19713210
• Report Number: 3005075853-2024-04979
• Device Sequence Number: 8608549
• Product Code: GEA
• UDI-Device Identifier: 10705036013372
• UDI-Public: 10705036013372
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K920110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: TT012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown