• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON INC. VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Pain (1994); Seroma (2069); Urinary Retention (2119); Hernia (2240)
Event Date 08/10/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Attempts are being made to clarify 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 surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? if so, please specify. Does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Patient demographics? (b)(4). 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 number has not been provided. The single complaint was reported with multiple events. There are no additional details regarding the additional events. Events related to prolene mesh captured via 2210968-2021-03653. Events related to unknown ethicon mesh captured via 2210968-2021-03652. Citation: https://doi. Org/10. 1007/s11701-020-01140-0.
 
Event Description
Title: safety and efficacy of robotic-assisted groin hernia repair. This retrospective study aims to evaluate the safety and efficacy of robotically assisted transabdominal preperitoneal (tapp) inguinal hernia repair over a 3-year period at a large, academic institution. From march 2015 to april 2018, a total of 43 patients (40 males, 3 females) with mean age of 56 years (range 18¿85 years) who had undergone robotic inguinal hernia repair were included in the study. Twelve of the patients had bilateral hernias confirmed during surgery, which led to a total of 55 hernias repaired. During one planned bilateral inguinal hernia repair, one side was not repaired due to a difficult repair on the other side involving a large hernia sac and eventual orchiopexy. In total, 54 hernias were repaired robotically (27 left and 27 right). During the procedures, all hernias were performed through a tapp approach, requiring the use of three trocars. Following dissection and reduction of the hernia sac, fixation of a synthetic polypropylene mesh (ethicon) with glue, tacks, sutures, or a combination of these materials was performed at the discretion of the surgeon. All of the operations were performed transabdominally and all but one included formal fixation of synthetic polypropylene mesh. Twenty-six of surgeries were performed with seven with prolene soft mesh (ethicon), and two with ethicon mesh. Regarding mesh fixation, 23 patients had suture only, 14 had tacks only, one had a combination of suture and tacks, two had suture and glue, and two had tacks and glue. Following the undocking of the robot, the incisions were closed primarily, and the patient was either discharged home or admitted for observation. Median follow-up was 37. 5 days reported complications included : one patient was observed overnight for treatment of urinary retention (n
=
1), severe postoperative pain (n
=
1) where patient was kept for one or two nights, seromas (n
=
11), one patient had a groin hematoma (n
=
1), by the third follow-up appointment, an average of 113 days postop, the hematoma and all of the seromas had resolved, at a median follow-up of 37. 5 days, there was one recurrence(n
=
1). This hernia was discovered incidentally during a urological procedure and was repaired at that time using the robot with a temporary, absorbable vicryl mesh (ethicon) to prevent immediate postoperative incarceration or infection. The patient¿s hernia recurred 5 months after this temporary repair, but because he was asymptomatic and concerned about the risks of surgery, he elected to manage the hernia nonoperatively it was concluded, that the robotic approach to inguinal hernia repair is safe and effective and should be considered a viable alternative to both laparoscopic and open repairs. Longer term studies will further define the role of this technology.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-SAN ANGELO
3348 pulliam street
san angelo TX 76905
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11708908
MDR Text Key262970535
Report Number2210968-2021-03651
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K810428
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/22/2021 Patient Sequence Number: 1
-
-