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 06/03/2016

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.The actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch# hjs557, exp date: 07/31/2019, mfr date: 08/01/2014.Batch# gdx556, exp.Date: 01/31/2018, mfr.Date: 04/01/2013.In addition, a review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria.Additional information was requested and the following was obtained: the holes were in the foil outer packaging were there holes/tears in the sterile primary packaging? were there holes/tears/punctures in the tyvek the compromised sterility (open or incomplete seal)?.

Event Description

It was reported that the patient underwent an unknown procedure on unknown date and the suture was used.It was also reported that the holes were in the foil outer packaging.Another like device was opened to complete the procedure.

Manufacturer Narrative

Manufacturer Narrative

In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.The foil was examined for visual inspection and it was observed many wrinkles in the top and bottom foil.The foil was examined and an aperture was found on the bottom foil and pleat was observed together.Also, there are several holes on the bottom foil and the holes are from outside to inside.The sample had undergone excessive handling.According the sample condition, suggests an improper handling of the sample.

• 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: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5921139
• MDR Text Key: 53703445
• Report Number: 2210968-2016-12410
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• 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: EZ10G
• Device Lot Number: HJS557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/13/2014
• 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