MAUDE Adverse Event Report: ETHICON INC. ENDOLOOP LIGATURE WITH PDS II; LAPROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number EZ10G

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.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.Can you identify the lot number of the product that was used?.

Event Description

It was reported that the patient underwent a laparoscopic procedure on (b)(6) 2017 and the suture was used.During the procedure, the suture packaging had a pin hole in it.Another like device was used to complete the procedure.There were no patient consequences reported.Additional information has been requested.

Manufacturer Narrative

During the visual inspection of the sample, the foil presents many wrinkles in the top and bottom foil and there are several holes from outside to inside on the bottom.No defects were found on the cannula and the suture has a knot near to the end suture.The sample was tested by tensile strength and the sample met the requirements.According to the sample conditions, suggest an improper handling of the sample.

Manufacturer Narrative

The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

• Brand Name: ENDOLOOP LIGATURE WITH PDS II
• Type of Device: LAPROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra, km 1; 54; sao paolo 12240 -908; BR 12240-908
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6385875
• MDR Text Key: 69326137
• Report Number: 2210968-2017-31051
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: EZ10G
• Device Lot Number: AF3357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2016
• 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