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

Catalog Number 810081L

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

Patient Problem Nonresorbable materials, unretrieved in body (2276)

Event Date 08/28/2014

Event Type  Injury  

Manufacturer Narrative

It was reported that at the time of the initial procedure, the mesh was removed and another mesh was implanted.The plastic sheath remains retained in the patient.The patient will be scheduled for an mri in the future.The patient remains continent and is doing well.

Event Description

It was reported that a patient underwent an obturator sling procedure for the treatment of incontinence on (b)(6) 2014.During the procedure, a portion of the plastic protection surrounding the surgical device was cut at the skin edge in error by surgeon.A piece of the flexible plastic protection was left in the patient¿s right groin and could not be retrieved.The patient was discharged on (b)(6) 2014.Currently, the patient is reported as doing well.Additional information has been requested.

Manufacturer Narrative

(b)(4).Conclusion: user error caused the event.A portion of the plastic protection surrounding the surgical device was cut at the skin edge in error by surgeon.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: GYNECARE TVT OBTURATOR 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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4112984
• MDR Text Key: 12289152
• Report Number: 2210968-2014-13637
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K033568
• 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,Followup
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Catalogue Number: 810081L
• Device Lot Number: 3782411
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2014
• 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): Other
• Patient Age: 52 YR