MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*MULTIFEED STAPLER; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number EMS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Seroma (2069); Swelling (2091); Urinary Retention (2119); Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.As a lot/batch was not provided, a device history could not be performed.

Event Description

It was reported via journal article: title: "effectivity of laparoscopic inguinal hernia repair (tapp) in daily clinical practice: early and long-term result," author(s): florian muschalla, jochen schwarz, reinhard bittner.Citation: surg endosc (2016) 30: 4985¿4994; doi 10.1007/s00464-016-4843-8.This prospective randomized study aimed to investigate the effectiveness of laparoscopic inguinal hernia repair in daily clinical practice.Between jan2000 and jan2001, 787 patients (n=91% male and n=9% female; median age of 60 years [17-92 years]) with a total of 1010 hernias were operated using transabdominal preperitoneal patch plasty (tapp).In the procedure, a prolene mesh, measuring 10x15cm was implanted and was fixed using ems staples (jnj).The peritoneum was closed with a running pds suture.Postoperative complications included urinary retention (n=7), mesh infection (n=2), seroma (n=2) treated by revision, testicular swelling (n=2), epididymitis (n=1), ileus (n=1) which was re-operated using laparoscopy by reducing the incarcerated bowel and closure of the gap using suture, infected seroma (n=1), and urinary tract infection (n=1).One of the two cases of mesh infection developed in a (b)(6) male patient for which he underwent partial mesh explantation at the long-term follow-up.Long term follow up complications included persistent seroma (n=6) treated with anterior revision with excision of the seroma capsule (n=2) and the others (n=4) were treated conservatively, mild chronic pain (n=28) which none needed painkillers, moderate chronic pain (n=10), severe chronic pain (n=6) which none needed analgesic treatment.Recurrence were observed in four patients.One patient was treated by covering using 10x15cm meshes overlapping each other, but still had recurrent hernia and was treated by covering the whole groin with 21x26cm large composite mesh in which the previously implanted meshes were left in place.At follow-up five years, this patient was feeling well without any signs of recurrence.In second patient, no reoperation had been carried out.The third was not willing to undergo reoperation as he had no complaints.In fourth patient, the defect was treated by covering using 3 meshes, 15x15 cm each, and no complaints or signs of recurrence post-treatment.Tension is one of the factors which may cause pain in inguinal hernia repair.Therefore, the patient with a preperitoneal mesh will experience less pain with ensuing more rapid recovery.Laparoscopic repair can be applied to all types of inguinal hernia as a daily routine procedure with low rates of recurrences and chronic pain.Limiting factor may be extensive adhesions after previous major surgery in the lower abdomen.

• 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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8059418
• MDR Text Key: 126962766
• Report Number: 3005075853-2018-14328
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K913469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EMS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1