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

Model Number	TT012
Medical Device Problem Codes	Crack (1135); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.
Event or Problem Description
It was reported that during an unknown procedure, one of devices was broken off when a camera was removed through it.The procedure was thoracoscopic surgery for pulmonary malignant tumor.The tip of the sleeve was broken.The broken pieces was retrieved from the patient.Doctor thought the trocar may be broken when sandwiched between the camera and costa.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/21/2020.H2: additional information received: the procedure was thoracoscopic surgery for pulmonary malignant tumor.The tip of the sleeve was broken.The broken piece was retrieved from the patient.Doctor thought the trocar may be broken when was sandwiched between the camera and costa.

• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 11016978
• Report Number: 3005075853-2020-06867
• Device Sequence Number: 3594156
• Product Code: GEA
• UDI-Device Identifier: 10705036013372
• UDI-Public: 10705036013372
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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 Expiration Date: 05/31/2025
• Device Model Number: TT012
• Device Catalogue Number: TT012
• Device Lot Number: U40D94
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 12/21/2020
• Patient Sequence Number: 1