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

Model Number	TT012
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 4/5/2023.D4: batch # unk.Additional information was requested and the following was obtained: "did any pieces fall into the patient? if yes, were they retrieved? yes, it fell off but retrieved." "there was no change in procedure (e.G.Additional porthole, additional wound) when retrieving the broken piece from the chest.The patient is stable.The surgeon's comment: the intercostal was narrow so there is a possibility that tip was deformed and damaged due to the pressure.And also, i have a similar experience in the past.The broken piece will be returning with the device." 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 tip of the sleeve broken.In addition, the packaging opened was returned along with the instrument.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.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
Event or Problem Description
It was reported that during a thoracoscopic pneumonectomy, the trocar could not be locked properly, and it was found that tip was broken.The broken piece was retrieved.Another device was used to complete the case.There were no adverse consequences to 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: 16681807
• Report Number: 3005075853-2023-02256
• Device Sequence Number: 20862022
• Product Code: GEA
• UDI-Device Identifier: 10705036013372
• UDI-Public: 10705036013372
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2023

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 Model Number: TT012
• Device Catalogue Number: TT012
• Device Lot Number: 887A89
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown