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 Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2023

Event Type  Injury  

Event Description

It was reported that during an unknown surgery, the device was broken.1 piece was not found.The surgery completed after confirmed by the surgeon.The patient is under 14-day observation and in good condition now.

Manufacturer Narrative

(b)(4).Date sent: 8/7/2023.D4: batch # unk.Additional information was requested and the following was obtained: "received pcf answer from sales rep via phone: what was the procedure type? lung cancer.What is the surgeons experience with this device? good.What is the patients bmi? unknown.What action was being performed when the device broke? tried to find all the pieces.What was the anatomical position of this specific port? seventh rib on the left bottom.What was this port¿s correlation to the patient¿s ribs? unknown.Is it possible the trocar point made contact with the ribs upon insertion? no.Were there any other intra op complications? no.Was there excessive torquing of the instrument at the time of the breakage? no.What instruments were passed through the trocar? lens.Has there been any re-operations/attempts to look for the pieces left in the patient (or plans to do re-operation)? no.Did the pieces left in the patient change the post-op care? no.Does the account use reprocessed trocars or does the account reprocess the trocars in house at the account? no." a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.

Manufacturer Narrative

(b)(4).Date sent: 9/14/2023 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 b12lt device was received with the tip of the sleeve broken and no pieces were returned.In addition, the packaging opened was returned along with the instrument.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.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 5/22/2024.D4: batch # unk.Additional investigation summary : in a further analysis from rdl material lab: the macro image of the broken tip (images 1) show that there was very little plastic deformation of the canula and multiple cracks propagating away from the main broken section.Higher magnification images of the fracture surface (images 2 and 3) show a primarily brittle type fracture.

• 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: 17477198
• MDR Text Key: 320582927
• Report Number: 3005075853-2023-05565
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001164
• UDI-Public: 10705036001164
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• 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?: No
• Device Operator: Health Professional
• Device Catalogue Number: B12LT
• Device Lot Number: 168C67
• 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: 08/07/2023
• Supplement Dates Manufacturer Received: 08/23/2023; 05/22/2024
• Supplement Dates FDA Received: 09/14/2023; 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other