MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. XCEL DILATING TIP TROCAR 12MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number D12LT

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4) date sent: 12/27/2023 d4: batch # unk additional information was requested and the following was obtained: "which kind of procedure ¿ minimal invasive oesophagectomy - when did it happen upon placement of the trocar or during the actual surgery when instruments where in it ¿ during the procedure, when the camera was in it.The broken trocar was the camera port.- how long was the surgical delay because of it ¿ around 10 minutes - did they retrieve all pieces - yes - any changes in the post-operative care of the patient ¿ no, patient went home as planned.- any significant medical history of the patient ¿ did not ask this" 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 Description

It was reported that during a minimal invasive oesophagectomy procedure, the tip of the trocar broke in pieces.The pieces were in the thorax of the patient and the surgeon had to retrieve all of them out of the thorax.

Manufacturer Narrative

(b)(4).Date sent: 4/16/2024.Potential impacted lot numbers: 339c05 or 179c68.D4.Lot: 339c05; d4.Expiration date: 2/29/2028; h4.Device manufacture date: 3/16/2023.D4.Lot: 179c68; d4.Expiration date: 10/31/2027; h4.Device manufacture date: 12/14/2022.

Manufacturer Narrative

(b)(4).Date sent: 2/20/2024.D4: batch # unk.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 only the sleeve from the d12lt device was received with the tip of the sleeve broken.In addition, the pieces of plastic from the sleeve were returned inside a plastic bag.No conclusion could be reached regarding what may have caused the reported incident.One possible cause for the damage found may be due to excessive force being applied to the device.Please refer to the instructions for use for additional information regarding proper device usage.The manufacturing records couldn't be reviewed as the batch number is unknown.

Manufacturer Narrative

(b)(4).Date sent: 2/27/2024.H6.Health effect - impact code.

• Brand Name: XCEL DILATING TIP TROCAR 12MM
• Type of Device: LAPAROSCOPE, GENERAL AND 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: 18399253
• MDR Text Key: 331504240
• Report Number: 3005075853-2023-09875
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001577
• UDI-Public: 10705036001577
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K032676
• 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,Followup,Followup
• Report Date: 04/16/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: D12LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 01/30/2024; 01/30/2024; 03/25/2024
• Supplement Dates FDA Received: 02/20/2024; 02/27/2024; 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1