MAUDE Adverse Event Report: ETHICON INC. PDS*II VLT 0 45CM - ENDOLOOP; LAPROSCOPE, GENERAL & PLASTIC SURGERY

Model Number EZ10G

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

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.Did the suture separate from the needle during the procedure or did the suture break during the procedure? were there any adverse patient consequences? procedure name and date? device return status/follow up? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that the patient underwent an unknown surgery on an unknown date and suture was used.The suture separated during the procedure.There were no adverse patient consequences reported.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 11/04/2020.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: it was reported that the suture separated.One empty open foil and a cannula with a suture of product code ez10, lot am9069 were received for analysis.During visual inspection of the sample, the scored point was noted broken due to use and the end was cut appears to be by use of surgical instrument.In addition, body fluids were observed on the strand.Standard endoscopic procedures should be followed up to the point of tissue ligation or approximation.The endoloop ligature is then introduced through a cannula.An appropriate surgical instrument is used to grasp and position the tissue.This may involve either pulling the tissue through the loop or encompassing the tissue with the loop.The endoloop ligature tube is then broken at the scored point.This allows the tube to slide over the suture and cinches the loop around the tissue.When the ligature has provided hemostasis the suture is cut behind the knot leaving an appropriate length of suture ¿ear¿.The tube is then removed.Several ligatures may be applied to ensure hemostasis or tissue approximation.It should be noted that as part of our quality process, device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Type of Device: LAPROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10535501
• MDR Text Key: 206988224
• Report Number: 2210968-2020-06917
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10705031206427
• UDI-Public: 10705031206427
• Combination Product (y/n): N
• PMA/PMN Number: K843187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EZ10G
• Device Catalogue Number: EZ10G03
• Device Lot Number: AM9069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Date Manufacturer Received: 10/09/2020
• Patient Sequence Number: 1