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

Catalog Number XCEL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Post Operative Wound Infection (2446)

Event Date 04/07/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Publication date of journal article: 1/19/2022 this report is related to a journal article; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our quality process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.If the product or additional information is received at a later date, the investigation will be updated as applicable.Attempts are being made to obtain additional information.To date, no additional information has been received.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.

Event Description

It was reported that during review of journal article: title: e-tep repair for midline primary and incisional hernia: technical considerations and initial experience authors: m.Khetan, a.Dey, v.Bindal, j.Suviraj, t.Mittal, s.Kalhan, v.K.Malik, b.Ramana citation: hernia (2021); 25:1635¿1646.Https://doi.Org/10.1007/s10029-021-02397-6.The aim of this retrospective study was to present the authors' initial experience of this approach and detailed steps of their native technical modifications in overcoming the challenges in performing this complex and potentially challenging procedure.A total of 58 patients (31 male and 27 female; mean age of 53.8±11 years; mean bmi of 29.3±4 kg/m2) who underwent enhanced-view totally extra peritoneal rives-stoppa (e-tep-rs) with and without transversus abdominis release (tar) for midline, large, complex, ventral abdominal hernias between march 2018 and december 2019 were included in the study.Surgery was performed using 12 mm excel trocar (ethicon), 5 mm excel trocar (ethicon), and harmonic scalpel (ethicon).Any accidental holes in the peritoneum are closed using 3¿0 pds interrupted sutures.A soft prolene mesh (ethicon) was used in 6 cases while an unknown medium or heavy weight polypropylene mesh was used in the rest of the cases.Follow-up ranged from 6 to 22 months, with a mean of 14 months.Reported complications include wound infection (n=1).In conclusion, the e-tep-rs technique for large, complex, midline, ventral abdominal hernias can be used with excellent results and acceptable morbidity.This technique is technically challenging and should be mastered in relatively smaller ventral hernias to achieve good results before attempting it in larger, complex ones.

• Brand Name: ENDOPATH XCEL TROCAR
• Type of Device: 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 ; *
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 13553353
• MDR Text Key: 291498644
• Report Number: 3005075853-2022-00922
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• 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: Physician
• Type of Report: Initial
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XCEL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention