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	02/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a vats pneumonectomy, the tip of the device was severely broken when a camera was inserted through the device and used.The device was used on the lung.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).Batch # unk additional information received: the broken pieces of the tip of the device fell into the patient.These were retrieved from a semi-open wound by forceps.The procedure was not converted.The patient¿s condition is stable.Attempts are being made to obtain additional information and to retrieve the device.To date, no additional information has been received and no device has been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent: you reported the procedure was not converted to an open procedure.Was the semi-open wound incision part of the routine procedure being performed? or was the semi-open wound incision a change to the procedure? was the semi-open wound incision still small enough to be considered a laparoscopic procedure? or was the semi-open wound incision too large to still be considered laparoscopic procedure? the lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/5/2022.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 only the sleeve from the tt012 device was received with the tip broken and a pieces inside a petri dish.The event reported was confirmed and it is related to improper use of the device.One possible cause for the damage found on the sleeve may be excessive external load placed on the device.Please reference the instruction for use for more information.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 468a21, and no non-conformances were identified.Additional information was requested, and the following was obtained: was the semi-open wound incision part of the routine procedure being performed? or was the semi-open wound incision a change to the procedure? routine procedure.Was the semi-open wound incision still small enough to be considered a laparoscopic procedure? or was the semi-open wound incision too large to still be considered laparoscopic procedure? japanese respiratory surgery of laparoscopic surgery, often with small incisions of 4-5 cm or more.We have not received any response that a trocar was added or a skin incision was made in this case.

• Common Device Name: CANNULA, SURGICAL, GENERAL, & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 13691707
• Report Number: 3005075853-2022-01381
• Device Sequence Number: 5170667
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2022

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: 08/31/2026
• Device Model Number: TT012
• Device Catalogue Number: TT012
• Device Lot Number: 468A21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 04/05/2022
• 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