MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. XCEL DILATING TIP TROCAR 11MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number D11LT

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.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.

Event Description

It was reported that the product was in stock of finished products at distributor and when sorting for shipping to the customer, it was noted that the paper pouch had a hole.In evaluating, it was noted a small bulge of the product, which may have caused the hole in the packaging, losing its sterility.This small bulge may have caused the hole due to friction with the pouch.There was no patient involvement.

• Brand Name: XCEL DILATING TIP TROCAR 11MM
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9575067
• MDR Text Key: 202547277
• Report Number: 3005075853-2020-00212
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001560
• UDI-Public: 10705036001560
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2019

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: 04/30/2021
• Device Catalogue Number: D11LT
• Device Lot Number: N4LJ45
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1