MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT RETROPUBIC SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 810041B

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problems Nonresorbable materials, unretrieved in body (2276); Surgical procedure, additional (2564)

Event Date 01/20/2014

Event Type  Injury  

Event Description

It was reported that a patient underwent a sling procedure to treat incontinence on (b)(6) 2014.During the procedure, the plastic covering the mesh did not remove from mesh.The surgeon trimmed the mesh before removing the plastic and the surgeon opines that they did not leave a long enough piece of mesh/plastic to grab onto once it was passed through the abdomen.The surgeon tunneled through one incision to remove the plastic and also tried to retrieve it transvaginally.The majority of the plastic was removed with forceps, but a small amount remains in the patient.The procedure was completed and the patient was discharged from the hospital in the regular time frame.The surgeon plans to follow this patient closely.

Manufacturer Narrative

(b)(4).Conclusion: user error caused the event.The attending physician lost both visual and tactile control of the sheath during use.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: GYNECARE TVT RETROPUBIC SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20 2000 neuchatel; neuchatel ; SZ
• Manufacturer Contact: ellen reuss ; route 22 west po box 151; somerville, NJ 08876 ; 9082183095
• MDR Report Key: 3637343
• MDR Text Key: 3989342
• Report Number: 2210968-2014-01664
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: 810041B
• Device Lot Number: 3644480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention