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	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being made to retrieve the device.To date, 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 video was received for review.Was received for review.Review is in progress and not yet completed.Upon completion of video review, a supplemental medwatch will be sent.
Event or Problem Description
It was reported that during a laparoscopic pneumonectomy, the device was broken off during use.The broken pieces fell into the patient, but they were all retrieved.The broken piece was retrieved from the small incision which were opened already.Doctor thought the trocar was broken when the forceps were pressed to the trocar in the narrow area between ribs.The device was used on the lung.Another device was used to complete the case.There were no adverse consequences to the patient.The patient is stable.No further information is available.
Additional Manufacturer Narrative
(b)(4) date sent: 1/4/2021.H2: additional information received: a photo was received for review.Upon visual inspection of one photo, the following was observed: the photo shows a trocar from top view and the edge on the distal end can be seen broken.Based on the photo, the event described is confirmed, however no conclusion or root cause could be determined as no device was received for analysis.If the device is received for analysis at a later date, hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.(b)(4).Date sent: 1/4/2021 h11=corrected data=h2 h2: additional information received: a photo was received for review, not a video.
Additional Manufacturer Narrative
(b)(4), date sent: 1/26/2021.D4: batch # unk.H6: component code: mechanical (g04).Investigation summary: the product was returned for evaluation.In addition, two plastic pieces were returned inside a plastic jar.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the tt012 device was received with the tip of sleeve broken.The reported complaint was confirmed.It should be noted that product failure is multifactorial.One possible cause for the damage found on the sleeve, may be due to an excessive external load being placed on the device.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.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.

• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 11024878
• Report Number: 3005075853-2020-06916
• Device Sequence Number: 10929637
• 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,Followup
• Report Date (Section B): 11/24/2020

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 Model Number: TT012
• Device Catalogue Number: TT012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 12/07/2020; 01/05/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/04/2021; 01/26/2021
• Patient Sequence Number: 1