MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*THORACIC TROCAR SLEEV

Model Number TT012

Device Problem Crack (1135)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/06/2022

Event Type  Injury  

Event Description

It was reported that during a thoracoscopic left lobectomy, the sleeve was broken off while a camera was operated after the device was used for about 2 hours.The device was used on the mid-axillary line in the 6th.The device was removed from the patient and checked, then it was found that a 1mm fragment was left inside the patient.The intrathoracic lavage was performed but it could not be found.The surgeon thought it is not a problem because it was very small.The procedure was not converted.The patient¿s condition is stable.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

(b)(4).Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.No lot or batch number was provided therefore a device history could not be done.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: can you describe the size and shape of the piece that was broken off? what type of instruments were exchanged through the trocar sleeve? were any sharp instruments exchanged through the trocar sleeve? are pictures of the device available? was there any alleged deficiency of trocar sleeve? what is the current patient status? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 6/6/2022 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 tt012 device was received with the tip of the sleeve cracked.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.Additional information was requested, and the following was obtained: can you describe the size and shape of the piece that was broken off? => about 1.5mm what type of instruments were exchanged through the trocar sleeve? => when the trocar sleeve broken, the camera was used.Were any sharp instruments exchanged through the trocar sleeve? => no further information is available.Are pictures of the device available? =>the device was returned.Was there any alleged deficiency of trocar sleeve? => no.What is the current patient status? =>the patient's condition is stable.No further information will be provided.

• Type of Device: ENDOPATH*THORACIC TROCAR SLEEV
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo
• MDR Report Key: 14169570
• MDR Text Key: 289767811
• Report Number: 3005075853-2022-02549
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10705036013372
• UDI-Public: 10705036013372
• Combination Product (y/n): N
• PMA/PMN Number: K920110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TT012
• Device Catalogue Number: TT012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention