MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*PROBE PLUS II HANDLE; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number EPH04

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 1/17/2023.Unknown; captured as awareness date.Batch #: v94j5y.Attempts have been 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.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.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, or its employees that the report constitutes an admission that the product, ethicon, 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.

Event Description

It was reported that before an unknown procedure ¿the adhesive on the box separated so therefore it is no longer sterile.¿ no injuries or adverse event was reported.

Manufacturer Narrative

(b)(4).Date sent: 3/23/2023.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.The device was returned sealed in its original packaging.Upon visual inspection, a stain that appears to be oil was observed on the tyvek of the packaging and in this area, the tyvek came loose.No conclusion could be reached as to what caused the issue reported.All ees product is 100% inspected prior to release.The information you provided is compiled monitored and reviewed on a routine basis for any associated trends.As part of the quality process all devices are manufactured, inspected, and released to approved specifications.

Manufacturer Narrative

(b)(4) date sent: 2/2/2023 this is an analysis of a set of images submitted for evaluation.Image 20221227_075010 and 20221227_074953: the image provided by the customer shows a sterile package.The seal appears to be damaged.Image 20221227_075000: the image provided by the customer shows a sterile package.No conclusion could be reached as to how this issue occurred through photo analysis.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.

• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16184221
• MDR Text Key: 308926901
• Report Number: 3005075853-2023-00351
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001874
• UDI-Public: 10705036001874
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K912492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPH04
• Device Catalogue Number: EPH04
• Device Lot Number: V94J5Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR