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	09/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Attempts are being made 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.Additional information received: a photo was received for review.Review is in progress and has not yet been completed.Upon completion of photo review, a supplemental medwatch will be sent.
Event or Problem Description
It was reported that during a vats lobectomy, the port was broken when the camera was inserted through the device.No pieces were left inside the patient.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), date sent: 10/14/2021, d4: batch # u40532.H2: additional information received: a photo was received for review.During the visual analysis, the following was observed: the photo shows a black sleeve, 12 mm, on a napkin and was noted to be broken.Based on the photo review, the event described is confirmed, however no conclusion or root cause could be determined.Please refer to the device analysis below for full analysis details and conclusion.Investigation summary the product was returned for evaluation.Visual inspection was conducted on the returned device.Upon visual analysis of the returned sample, it was determined the tt012 device was received with the tip of the sleeve broken and the remainder was returned inside of a plastic jar.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 due to an excessive external load being placed on the device.Please reference the instructions for use for more information.As part of our quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 12516497
• Report Number: 3005075853-2021-05663
• Device Sequence Number: 13684112
• 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): 10/14/2021

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: 02/28/2025
• Device Model Number: TT012
• Device Catalogue Number: TT012
• Device Lot Number: U40532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/14/2021
• Patient Sequence Number: 1