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

Model Number B12LT

Device Problem Crack (1135)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/17/2023

Event Type  Injury  

Event Description

It was reported that during a laparoscopic partial hepatectomy, it was found the 5mm from the tip was broken when the trocar was removed for wound closing.The floor, drape, bin, suctioned contents were checked, and the x-ray was performed, but the broken piece was not found.Another device was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Date sent: 5/16/2023.D4: batch # unk.Additional information was requested and the following was obtained: ""are any photos of the device available?? yes, please see the attached file in notes tab.What instruments went through this trocar? it's currently being confirmed.Was there excessive torquing of any devices through this trocar? no.Were any of the instruments that went through this trocar energized (electrosurgical or ultrasonic)? it's currently being confirmed.If any endocutters were removed from the trocar, was it confirmed that they were completely straight prior to removal? i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted in ecm note.Was this trocar placed near the patient's rib? i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted in ecm note.What is the patient bmi? i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted in ecm note.Were any pieces of the broken off tip found? no."" 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: 5/24/2023.D4: batch # x95w0a.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 b12lt device was received with the tip of the sleeve broken.In addition, the piece of plastic from the sleeve was not returned.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 were reviewed and the manufacturing criteria were met prior to the release of this batch.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.

Manufacturer Narrative

(b)(4).Date sent: 6/19/2023.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 instruments went through this trocar? were any of the instruments that went through this trocar energized (electrosurgical or ultrasonic)? if any endocutters were removed from the trocar, was it confirmed that they were completely straight prior to removal? was this trocar placed near the patient's rib? what is the patient bmi?" photo analysis: this is an analysis for a photo submitted to ethicon for evaluation: during the visual analysis, the following was observed: the photo shows an endopath xcel bladeless trocar with product code b12lt.A clear analysis could not be performed as the photo becomes distorted when magnified.Based on the photo review, the event describe is not confirmed, however no conclusion or root cause could be determined.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.The manufacturing records could not be reviewed as the batch number is unknown.

Manufacturer Narrative

(b)(4).Date sent: 7/26/2023.D4: batch#: unk.Additional information was requested and the following was obtained: what instruments went through this trocar? were any of the instruments that went through this trocar energized (electrosurgical or ultrasonic)? if any endocutters were removed from the trocar, was it confirmed that they were completely straight prior to removal? was this trocar placed near the patient's rib? what is the patient bmi? certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted in ecm note.

Manufacturer Narrative

(b)(4).Date sent: 11/22/2023.D4: batch # x95w0a.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 b12lt device was received with the tip of the sleeve broken.In addition, the piece of plastic from the sleeve was not returned.In a further analysis of the device: a material analysis was performed on the returned device.The macro images show that there was plastic deformation of the sleeve, but there does not appear to be cracking or crazing.Higher magnification of the fractured surface shows that the fracture is ductile, not brittle.See attachment.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 batch and lot number, and no non-conformances were identified.

• 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: 16942195
• MDR Text Key: 315331978
• Report Number: 3005075853-2023-03335
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001164
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: B12LT
• Device Catalogue Number: B12LT
• Device Lot Number: X95W0A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other