MAUDE Adverse Event Report: ETHICON INC. MERSILENE TAPE UNKNOWN PRODUCT; INSTRUMENT, SURGICAL, DISPOSABLE

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

Patient Problems Adhesion(s) (1695); Erosion (1750); Inflammation (1932); Pain (1994); Injury (2348); Not Applicable (3189)

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.Attempts are being made to obtain 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.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? citation: the journal of reproductive medicine volume 62, number 1-2, january-february 2017.(b)(4).

Event Description

It was reported via journal article: title: "a further application of detachable snare loops (endoloop) for repair of bladder injury," author(s): theodore tsaltas, m.D., citation: the journal of reproductive medicine volume 62, number 1-2, january-february 2017.This study reported a case of a (b)(6) female patient who underwent shirodkar cerclage due to extensive cervical destruction from 2 prior procedures for dysplasia.She complained of dyspareunia and a vaginal mass (cervix scarred to the anterior vaginal wall down the vaginal barrel).Pressure on the cervix or uterine motion produced pain.She was advised to undergo laparoscopic hysterectomy.During the laparoscopic hysterectomy, extensive adhesion and inflammation were encountered anterior to the cervix managed by laparoscopic and vaginal dissection.After removal of the uterus, mersilene tape (used shirodkar cerclage) was noted during the closure of the vaginal cuff.Laparoscopic examination showed a 5mm tear in the bladder.The timing and location of the findings were compatible with the openings of an erosion created and occluded by the mersilene knot.Pathology confirmed extensive inflammation and erosion compatible with ulceration.Extensive inflammation precluded observational management.The bladder tear was managed in which the edges of the tear were closed using a laparoscopic allis forceps and a 0 pds endoloop.Irrigation showed the bladder intact.The ureters were patent and functioning.The injury site was watertight.This technique allows for rapid repair of even difficult bladder injuries of appropriate size under complex conditions.

• Brand Name: MERSILENE TAPE UNKNOWN PRODUCT
• Type of Device: INSTRUMENT, SURGICAL, DISPOSABLE
• 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: 8180897
• MDR Text Key: 130895619
• Report Number: 2210968-2018-77904
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2018
• 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