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

Model Number B5LT

Device Problem Use of Device Problem (1670)

Patient Problem Nerve Damage (1979)

Event Date 09/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 devices caused or contributed to the patient complications mentioned in the article? if yes, please explain.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.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 via journal article; title: the effect of transvestibular endoscopic surgery on the cosmetic outcome and long-term prognosis of patients with unilateral thyroid carcinoma.Authors: he liang, li leilei, wu yalei, qiu zhenglun, zhang yanfang.Citation: chinese journal of clinical practical medicine, february 2021, vol.12, no.1, doi: 10 3760/cma j cn115570 ¯ 20200914 01423.The objective of the study was to investigate the effect of transoral vestibular approach endoscopy on the cosmetic outcome and long-term prognosis of patients with unilateral papillary thyroid carcinoma.From november 2017 to december 2019, 80 patients with unilateral papillary thyroid carcinoma were included in the study.The patients were randomly divided into the total areola approach group and the transoral vestibular approach group, with 40 patients in each group.In the total areola approach group, there were 8 males and 32 females with a mean age of 52.23 ± 5.32 years (range 35 to 67 years).In the transoral vestibular approach group, there were 9 males and 31 females with a mean age of 52.46 +/-5.58 years (range 33 to 65 years).In the total areola approach group, the 10 cm endopath xcel trocars model b5xt (ethicon endo-surgery) was punctured and placed at 15 cm incision while the 0.5 cm endopath xcel trocars model b5lt (ethicon endo-surgery) was punctured and placed at 2 0.5 cm incisions to separate the subcutaneous tunnel until an operating space was established in front of the neck to open the linea alba cervicalis to separate the anterior cervical muscle group.In the oral vestibular group, a 0.5 cm incision and placement of endopath xcel trocar model b8lt (ethicon endo-surgery), a competitor's monopolar electrotome, and a harmonic scalpel (ethicon endo-surgery) was performed to establish neck operating space and open the linea alba to expose the thyroid gland, cut off the thyroid canal, separate and transect the superior pole vessels of the thyroid gland, middle vein, etc.The free recurrent laryngeal nerve was explored to preserve the parathyroid gland and remove the thyroid gland frozen section on the lesion side.The reported complications included glandular function injury (n=1) and recurrent nerve injury (n=1).In conclusion, transoral vestibular endoscopic surgery in patients with unilateral papillary thyroid carcinoma has good clinical results and long-term prognosis and better cosmetic results.

Manufacturer Narrative

(b)(4).Date sent: 11/2/2022.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

• 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: orla o'mahony ; 475 calle c; guaynabo ; 329348013
• MDR Report Key: 15494996
• MDR Text Key: 300722232
• Report Number: 3005075853-2022-06472
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001225
• UDI-Public: 10705036001225
• 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,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B5LT
• Device Catalogue Number: B5LT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability