MAUDE Adverse Event Report: ETHICON INC. ENDOLOOP LIGATURE UNKNOWN PRODUCT; CANNULA, SURGICAL, GENERAL

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

Patient Problem Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

(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.Citation: int urogynecol j.2012; 23: 1137¿1139.Doi: 10.1007/s00192-012-1668-4.(b)(4).

Event Description

It was reported via journal article: "title: cystoscopic removal of intravesical synthetic mesh extrusion with the aid of endoloop sutures and endoscopic scissors: authors: jared m.Bieniek, tara l.Holste, raisa o.Platte, vatche a.Minassian citation: int urogynecol j.2012; 23: 1137¿1139.Doi: 10.1007/s00192-012-1668-4.The authors presented a case of intravesical polypropylene mesh extrusion following a combined mesh kit and midurethral sling placement.A novel transurethral approach, employing vicryl endoloop sutures (ethicon) with endoscopic scissors, was used to resect the protruding mesh located in close proximity to a ureteral orifice.A (b)(6) woman was presented to the hospital with mesh extrusion.It was reported that 4 years prior to presentation, she underwent mesh kit and mid-urethral sling placement.During the operative cystoscopy, a vicryl endoloop suture (ethicon) was introduced into the bladder adjacent to the cystoscope and passed under the band of mesh.A second endoloop suture was next secured around the remaining portion of the mesh and scissors used to excise the right exit site of mesh.Remaining mesh fibers were trimmed until no fibers were seen.Reported complications included necrotic debris at one of the mesh exit sites and two minuscule fibers near the other previous mesh exit site.The authors described a novel technique for excision of intravesical mesh extrusion using a transurethral approach with endoloop sutures and endoscopic scissors.By avoiding the use of an energy source, the authors reduced potential complications related to injury of surrounding structures within the bladder with no recurrence of mesh extrusion.

• Brand Name: ENDOLOOP LIGATURE UNKNOWN PRODUCT
• Type of Device: CANNULA, SURGICAL, GENERAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8200797
• MDR Text Key: 131582850
• Report Number: 2210968-2018-78060
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/27/2018
• 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
• Patient Age: 55 YR