MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL BLADELESS TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number B12LT

Device Problem Crack (1135)

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

Event Date 01/30/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 2/20/2024.D4: 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.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 laparoscopie-assisted colectomy, when the trocar was pulled out, the tip was deformed as if it peeled off.Possibility that piece of device had fallen into the patient's body.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 3/12/2024.D4: batch # unk.Additional information was requested and the following was obtained: what is the surgeons experience with the device?=>currently, unknown.Have there been any attempts to locate/remove the missing piece of the trocar from the patient? no.What instruments were passed through the trocar?currentl, unknown.Were any electrosurgical or ultrasonic harmonic devices used through the trocar? =>currently, unknown." 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 b12lt device was received with the tip damaged melted.The event reported was confirmed and it is related to improper use of the device.In order to prevent this kind of damage please avoid the contact with laser, electrosurgical or ultrasonic devices.The manufacturing records couldn't be reviewed as the batch number is unknown.

Manufacturer Narrative

(b)(4).Date sent: 5/22/2024 batch # unk additional investigation summary: in a further analysis from rdl material lab: the macro images of the broken tip (images 1,2) show the damaged lip and what appears to be damaged along the canula.Higher magnification images of the fracture surface (images 3) the fracture surface and that there is no other cracking around the missing section that would indicate an overall brittle failure.

• Brand Name: ENDOPATH XCEL BLADELESS TROCAR
• 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: 18742991
• MDR Text Key: 335809513
• Report Number: 3005075853-2024-01458
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 30705036001168
• UDI-Public: 10705036001164
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 05/22/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: B12LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 02/23/2024; 05/22/2024
• Supplement Dates FDA Received: 03/12/2024; 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other