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

Catalog Number EMS

Device Problem Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of events: (b)(6) 2008 and (b)(6) 2010 enrolled.No lot or batch number reported, therefore, a device history could not be done.Event description continued: after completing the dissection, we applied a large 3d-max mesh (16.0 x 10.8 cm; bard) or prolene, vypro, or ultrapro mesh (15x10 cm; ethicon) to cover the whole myopectineal orifice, with or without tacker fixation (auto suture protack, tyco).In the tapp procedure, the open peritoneum was sealed using an endoscopic multifeed stapler(ethicon) or a running 2-0 or 3-0 vicryl suture.Finally, the 10- or 12-mm port fascia was closed using a 2-0 vicryl suture (ethicon), and then the port sites were closed with running subcuticular stitch or skin glue.Results: among the 1,760 included patients (530 open and 1,230 laparoscopic), 96.08 % completed the follow-up (24¿60 months).Postoperative seroma was the most common short-term complication, and most developed in the patients with an undissected large sac, all of whom were treated conservatively.There was no significant difference between the two groups in terms of the incidence of postoperative seroma.One case of mechanical ileus occurred due to intestinal adhesion with the mesh, because the peritoneum was not completely sealed during the tapp procedure.The patient underwent laparotomy 3 months after the hernia surgery, in which the adhesion was dissected and the adhesive intestine was cut while preserving the mesh.After undergoing a tapp procedure, two patients developed enteroparalysis and were treated conservatively.Five patients in the open group had wound infection and one in the laparoscopic group had wound infection in the 12-mm trocar site; however, all of the infections were superficial and were treated effectively with a dressing.The overall recurrence rate in our study was (n = 12): 1.19 % (n = 6) in the open group and 0.51 % (n = 6) in the laparoscopic group.All recurrences occurred at 3¿35 months (median, 11 m) after surgery, and only two recurrences in the open group occurred later than 2 years after surgery.In 7 of 12 cases reoperated in our hospitals, the recurrence was due to technical factors.Four cases of recurrence were caused by a missed defect in the open group.One case of recurrence was caused by folding of the mesh in open group.One case was caused by inadequate overlapping; and another, by improper fixation in laparoscopic group.Among all the long-term complications, chronic pain contributed to the difference between the two groups.In addition, two cases of mesh-related infection were found in the open group at 8 and 29 months.In one case, the mesh was removed, and in the other, the patient was transferred to another hospital.In contrast, no mesh-related infection and trocar-site hernia were encountered in the laparoscopic group.

Event Description

"comparison of open and laparoscopic preperitoneal repair of groin hernia" authors: jianwen li ¿ xin wang ¿ xueyi feng ¿yan gu ¿ rui tang citation: surg endosc (2013) 27:4702¿4710 4703; doi 10.1007/s00464-013-3118-x it was reported via journal article, groin hernia patients older than 18 years who underwent open modified kugel (mk) or laparoscopic preperitoneal herniorrhaphy between january 2008 and december 2010 were enrolled.A total of 1,760 patients with 2,064 hernial sides of whom 530 underwent an open mk procedure and 1,230 underwent a laparoscopic preperitoneal procedure (451 tapp and 779 tep procedures).Open procedure: the open mk procedure was performed using a large oval mk hernia patch (bard).After closure of the external oblique and scarpa¿s fascia with a running 3-0 vicryl plus suture (polyglactin; ethicon), the skin incision was closed with a running subcuticular stitch.Laparoscopic procedure: in the tep operation, after entering the space in front of the posterior rectus sheath, we inserted a 10- or 12-mm trocar and dissected the central preperitoneal space from the umbilicus down to the pubis just with the aid of the telescope.After completing the dissection, we applied a large 3d-max mesh (16.0x10.8 cm; bard) or prolene, vypro, or ultrapro mesh (15x10 cm; ethicon) to cover the whole myopectineal orifice, with or without tacker fixation (auto suture protack, tyco).In the tapp procedure, the open peritoneum was sealed using an endoscopic multifeed stapler(ethicon) or a running 2-0 or 3-0 vicryl suture.Finally, the 10- or 12-mm port fascia was closed using a 2-0 vicryl suture (ethicon), and then the port sites were closed with running subcuticular stitch or skin glue.Results: among the 1,760 included patients (530 open and 1,230 laparoscopic), 96.08 % completed the follow-up (24¿60 months).-postoperative seroma was the most common short-term complication, and most developed in the patients with an undissected large sac, all of whom were treated conservatively.There was no significant difference between the two groups in terms of the incidence of postoperative seroma.-one case of mechanical ileus occurred due to intestinal adhesion with the mesh, because the peritoneum was not completely sealed during the tapp procedure.The patient underwent laparotomy 3 months after the hernia surgery, in which the adhesion was dissected and the adhesive intestine was cut while preserving the mesh.-after undergoing a tapp procedure, two patients developed enteroparalysis and were treated conservatively.-five patients in the open group had wound infection and one in the laparoscopic group had wound infection in the 12-mm trocar site; however, all of the infections were superficial and were treated effectively with a dressing.-the overall recurrence rate in our study was (n = 12): 1.19 % (n = 6) in the open group and 0.51 % (n = 6) in the laparoscopic group.All recurrences occurred at 3¿35 months (median, 11 m) after surgery, and only two recurrences in the open group occurred later than 2 years after surgery.In 7 of 12 cases reoperated in our hospitals, the recurrence was due to technical factors.Four cases of recurrence were caused by a missed defect in the open group.One case of recurrence was caused by folding of the mesh in open group.One case was caused by inadequate overlapping; and another, by improper fixation in laparoscopic group.Among all the long-term complications, chronic pain contributed to the difference between the two groups.In addition, two cases of mesh-related infection were found in the open group at 8 and 29 months.In one case, the mesh was removed, and in the other, the patient was transferred to another hospital.In contrast, no mesh-related infection and trocar-site hernia were encountered in the laparoscopic group.

Manufacturer Narrative

(b)(4).Report source is literature.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event.Additional information received: the complications were not related to the jnj devices.

• 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: 7040230
• MDR Text Key: 92312093
• Report Number: 3005075853-2017-06175
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup,Followup,Followup

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
• Device Operator: Health Professional
• Device Catalogue Number: EMS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 10/20/2017; 10/20/2017; 01/02/2018
• Supplement Dates FDA Received: 11/17/2017; 11/17/2017; 01/04/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1