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

Catalog Number	TT012
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) date sent: 10/16/2024 d4: batch # unk additional information was requested and the following was obtained: "were all fragments of the device retrieved from the patient? does the surgeon believe any pieces remain in the patient? the surgeon has recovered as much fragment as possible but when reconstructing the instrument from the recovered fragments, parts are missing.As a result, not all the fragments were recovered and some pieces remain according to the surgeon." 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during a right thoracoscopy video through two 12 mm thoracopports at the 5th intercostal space, a 12 mm surgical trocar is used.When the camera is inserted, the trocar is damaged and breaks into several fragments.The operator attempts to remove the fragments in the patient¿s chest.After reconstitution of the trocar with the fragments recovered in the patient's chest and on the operating field, it is found that several fragments are missing.Prolonged procedure 30 minutes possible presence of fragments in the patient¿s chest.Actions taken in the healthcare facility for patient care: searching for fragments of the trocar on the surgical field and in the patient¿s chest, removing certain plastic fragments.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/12/2024.D4: batch # unk.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: "what is the surgeons experience with device? were there any other intra op complications? was there excessive torquing of the instrument? what instruments were passed through the trocar? does the account use reprocessed trocars or does the account reprocess the trocars in house at the account? have any further attempts been made to locate the remaining fragments? what is the current patient status?" 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 sleeve from the tt012 device was received broken and pieces were returned.In addition pieces of the sleeve broken were returned inside a plastic bag.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.A manufacturing record evaluation was performed for the finished device lot 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 20465119
• Report Number: 3005075853-2024-07813
• Device Sequence Number: 18302389
• Product Code: GEA
• UDI-Device Identifier: 10705036013372
• UDI-Public: (01)10705036013372(17)271231(10)275C99
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: TT012
• Device Lot Number: 275C99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown