MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. XCEL DILATING TIP TROCAR 5MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number D5ST

Device Problem Crack (1135)

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

Event Date 02/12/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 3/13/2024.D4: batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Additional information was requested and the following was obtained: "yes, here's the consequence: pieces of plastic from the crumbling tip of the trocar found their way into the patient's abdomen.The pieces of plastic were removed from the abdomen." 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: "were all pieces of the trocar removed from the patient? was the procedure modified to retrieve the pieces from the patients abdomen? was patient post op care altered due to alleged device deficiency?" 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 an unknown procedure, tip of the trocar crumbled and left pieces of plastic in the abdomen.Used another device to complete the procedure.

Manufacturer Narrative

(b)(4).Date sent: 4/11/2024.Additional information was requested and the following was obtained: were all pieces of the trocar removed from the patient? we hope that yes, we have done the best.Was the procedure modified to retrieve the pieces from the patients abdomen? no, only a lengthening of the duration of the operation the time to recover the ends.Was patient post op care altered due to alleged device deficiency? no.

Manufacturer Narrative

(b)(4).Date sent: 4/24/2024.D4: batch # a9dz8d.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Additional information was requested and the following was obtained: there was a mistake regarding the impacted device." correct impacted device: product code d5st - lot a9dz8d.The issue was solved by changing the trocar".

Manufacturer Narrative

(b)(4).Date sent: 5/21/2024.D4: batch # a9dz8d.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 d5st devices was returned with the obturator inserted through the sleeve, for this reason the seal mechanism was found to be deformed.The device was visually inspected and no damaged found on the sleeve.The event described could not be confirmed as the device was returned without any damaged.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: XCEL DILATING TIP TROCAR 5MM
• 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: 18897679
• MDR Text Key: 337630822
• Report Number: 3005075853-2024-02170
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001607
• UDI-Public: 10705036001607
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/21/2024

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: D5ST
• Device Lot Number: A9DZ8D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 03/19/2024; 04/16/2024; 04/24/2024
• Supplement Dates FDA Received: 04/11/2024; 04/24/2024; 05/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/22/2023
• 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