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 Erosion (1750); Fever (1858); Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Injury (2348); Obstruction/Occlusion (2422); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Journal article publication year of 2019.This report is related to a journal article; therefore, no product will be returned for analysis.The lot/ batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being made to obtain the following information from the author: does the author believe that any of the negative/ adverse patient outcomes described in the journal article were directly related to an alleged deficiency in the ethicon ems stapler? to date, no response has been received.If further details are received at a later date, a supplemental medwatch will be sent.

Event Description

It was reported that during review of a journal article, title: medium-term outcome of laparoscopic sacrocolpopexy using polyvinylidene fluoride as compared to a hybrid polyglecaprone and polypropylene mesh: a matched control study.Authors: geertje callewaert, susanne housmans, laura cattani, stefaan pacquee, andre d¿hoore, jan wyndaele, frank van der aa, jan deprest; citation: neurourology and urodynamics.2019;38:1874-1882.Doi: 10.1002/nau.24083.The authors presented 2-year anatomical and functional outcomes as well as the occurrence of graft-related complications (grc) in unselected consecutive patients undergoing laparoscopic sacrocolpopexy (lscp) with polyvinylidene fluoride (pvdf) as compared to a matched cohort operated with hybrid polypropylene containing a resorbable polyglecaprone (pp + pg).This retrospective report deals with the first 105 patients (age: 67 [58-73] years; bmi: 26 [25-29]) in whom lscp was done using a pvdf implant (cases) (pvdf group).They were matched one-to-one to 105 controls (age: 68 [60-75] years; bmi: 25 [23-28]) operated before, using a hybrid pp + pg (ultrapro; ethicon) (pp + pg group).During the procedure, the anterior and posterior leaf were cut out of a large flat mesh.The mesh covering the anterior and posterior vaginal wall had a width of 5 cm, and a length that was based on the length of the vaginal dissection.The posterior leaf was in its sacral arm 3 to 4 cm in width.The mesh was sutured to the vagina with multiple, slowly resorbable polydioxanone sutures (pds; ethicon) in rows of three for each 2 cm of vagina covered.The posterior leaf was suspended tension free and fixed to the anterior vertebral ligament with a minimum of three staplers (ems; ethicon).The anterior leaf was sutured to the posterior mesh using up to three nonresorbable polyester sutures (ethibond; ethicon).Any excess amount of mesh was removed after fixation.Meshes were covered by peritoneum using one or more polyglecaprone 0 sutures (monocryl 0; ethicon).Reported complication in the pvdf group included vaginal wall perforation (n-1) which was closed primarily by laparoscopy, needle detached spontaneously from the suture (n-1) but could be easily retrieved, vascular injury (n-2), postoperative fever (n-1) in which the patient received antibiotics, persistent stress incontinence (n-9) in which patients the underwent reintervention, persistent urge incontinence (n-14), persistent obstructive voiding (n-2), persistent constipation (n-12), persistent obstructive defecation (n-2) in which the patients underwent redo-rectopexies, persistent dyspareunia (n-4), de novo stress incontinence (n-18) in which patients the underwent reintervention, de novo urge incontinence (n-15), de novo obstructive voiding (n-3), de novo constipation (n-15), de novo fecal incontinence (n-4), de novo dyspareunia (n-1), mesh exposure (n-2) which were successfully managed with vaginal excision under general anesthesia, bleeding or vaginal discharge (n-1), pelvic organ prolapse (n-2) in which the patients was reoperated (1 anterior repair and 1 posterior repair), and recurrent or persistent bulge (n-6).Reported complications in pp + pg group included bladder injury (n-1) which was closed primarily by laparascopy, vaginal wall perforation (n-3) which was closed primarily by laparoscopy, vascular injury (n-1), small bowel obstruction (n-1) in which the patient underwent adhesiolysis, urinary tract infection (n-14) in which the patient received antibiotics, vaginal infection (n-1) in which the patient received antibiotics, postoperative fever (n-3) in which the patient received antibiotics, urinary retention (n-1), persistent stress incontinence (n-9) in which patients the underwent reintervention, persistent urge incontinence (n-18), persistent obstructive voiding (n-7), persistent constipation (n-8), persistent fecal incontinence (n-2), persistent dyspareunia (n-2), de novo stress incontinence (n-15) in which patients the underwent reintervention, de novo urge incontinence (n-11), de novo obstructive voiding (n-3, de novo constipation (n-10), de novo fecal incontinence (n-7), de novo dyspareunia (n-3), mesh exposure (n-1) which were successfully managed with vaginal excision under general anesthesia, bleeding or vaginal discharge (n-1), pelvic organ prolapse (n-1) in which the patient reoperated (combined anterior and posterior repair), coccydynia (n-1) in which the patient insisted removal of the staples on the promontory, which was done successfully yet symptoms persisted, and recurrent or persistent bulge (n-16).In conclusion, a similar patient satisfaction and anatomical outcomes at level-i in patients undergoing lscp with pvdf as compared to matched-controls in whom a pp + pg mesh was used.Furthermore, the overall complication rate was low in both groups, suggesting both meshes can be safely and effectively used for lscp.

• 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 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 9845260
• MDR Text Key: 196408832
• Report Number: 3005075853-2020-01677
• 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,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2020
• 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): Required Intervention