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

Catalog Number	B12LT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	09/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 12/2/2025.D4: batch # unk.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.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: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.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 or Problem Description
It was reported via journal article: this complaint is from a literature source.The following literature cite has been reviewed: yuk fj, carr mt, schupper aj, lin j, tadros r, wiklund p, sfakianos j, steinberger j.Da vinci meets globus excelsius gps: a totally robotic minimally invasive anterior and posterior lumbar fusion.World neurosurg.2023 dec;180:29-35.Doi: 10.1016/j.Wneu.2023.09.028.Epub 2023 sep 13.Pmid: 37708971.This is a case study of 65-year-old man with chronic low back pain and left greater than right lower extremity radiculopathy was found to have grade 1 spondylolisthesis at l5/ s1 that worsened on standing upright.He underwent alif (anterior lumbar interbody fusion) using a da vinci robotic approach, followed by percutaneous posterior instrumented fusion with the globus excelsius gps robot and two 12- mm ethicon 512 nt camera ports, (johnson & johnson co.Somerville, new jersey, usa).Reported complications are n=1; 65 year old-man.Developed a brief episode of ileus for 2 days.Treatment: stool softeners and enemas.In conclusion, we report on the first all-robotic alif with posterior percutaneous pedicle screw fixation, using the da vinci robot for anterior access and the excelsius gps robot for pedicle screw placement.The robotic approaches to both anterior and posterior fusion provide accurate and safe instrumentation placement through a minimally invasive approach.All-robotic anterior/posterior lumbar fusion is technically feasible and resulted in an excellent outcome in our patient.

• Brand Name: ENDOPATH XCEL BLADELESS TROCAR
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 23696496
• Report Number: 3005075853-2025-09109
• Device Sequence Number: 16000535
• Product Code: GCJ
• UDI-Device Identifier: 10705036001164
• UDI-Public: 10705036001164
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: B12LT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male