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

Catalog Number 810081L

Device Problems Difficult to Remove (1528); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts are being made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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.Clarify the event: it was reported ¿the plastic sheath covering the mesh could not be removed and or come loose.¿ please explain what actually occurred did the clear plastic sheath that actually covers the mesh come loose or could the plastic sheath covering the mesh not be removed? confirm that it was the clear plastic sheath covering the mesh that present the quality issue and not the white sheath covering the helical passer? confirm that the event occurred intra-operative, as the surgeon attempted to place the device thus establishing patient contact? was any portion of this device retained in the patient or was the device removed from the patient in its entirely? provide lot number? procedure? date of the procedure? confirm procedure completed with new device opened? any patient consequences?.

Event Description

It was reported that the patient underwent a gynecological procedure on an unknown date and mesh was used.During the procedure, the plastic sheath covering the mesh could not be removed and or come loose.They opened a second device to complete the procedure.There were no adverse patient consequences reported.

Manufacturer Narrative

Device codes: 4008.The device received was manipulated: the mesh is cut, the plastic sheath was removed and not sent for evaluation.The defect seen during the product evaluation is not aligned with the defect described in the event description (damaged clear sheath).The plastic sheath was not sent for evaluation.No further investigation will be conducted on this complaint due to external cause.The manufacturing process could not create this defect.Additional information was requested, and the following was obtained: 1.Clarify the event: it was reported ¿the plastic sheath covering the mesh could not be removed and or come loose.¿ please explain what actually occurred did the clear plastic sheath that actually covers the mesh come loose or could the plastic sheath covering the mesh not be removed? the plastic sheath covering the mesh could not be removed.2.Confirm that it was the clear plastic sheath covering the mesh that present the quality issue and not the white sheath covering the helical passer? correct.3.Confirm that the event occurred intra-operative, as the surgeon attempted to place the device thus establishing patient contact? what do you mean establishing patient contact.Obviously the event occurred intraoperatively which is when it was removed and replaced with another tvto.4.Was any portion of this device retained in the patient or was the device removed from the patient in its entirely? i think my scrub sister would be been quite clear that the device was removed and replaced.The account should therefore reflect that only one tvto was left in situation whilst the other was removed, its lot number would be available to you.5.Confirm procedure completed with new device opened? any patient consequences? the patient suffered no consequence and was subsequently not even informed unless someone in billings put two mesh coded on.This was a courtesy notification for quality control and to ensure the patient would not be double billed.I hope this clarifies things somewhat.

Manufacturer Narrative

Method codes: 3331.The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.

• Brand Name: GYNECARE TVT OBTURATOR W LASR
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8343961
• MDR Text Key: 136317423
• Report Number: 2210968-2019-78910
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: 10705031062306
• Combination Product (y/n): N
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 810081L
• Device Lot Number: 3932650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Manufacturer Received: 01/21/2019
• Initial Date FDA Received: 02/15/2019
• Supplement Dates Manufacturer Received: 02/19/2019; 02/22/2019
• Supplement Dates FDA Received: 03/18/2019; 03/21/2019
• Patient Sequence Number: 1