MAUDE Adverse Event Report: ETHICON INC. 0 ENDOLOOP LIG W/PDS II; CANNULA, SURGICAL, GENERAL AND PLASTIC SURGERY

Model Number EZ10G

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 07/03/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).(b)(4).Device not returned.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.Additional information was requested, and the following was obtained: was there any hole, tear, or puncture that compromises sterility.Yes.Any open or incomplete seal?.No.Any ease or difficulty in removing the product or component of the product from the packaging that did not compromised its integrity/sterility? na.Do you have a photo for visual analysis? no.Did the packaging look damaged? sometimes yes, sometimes no.Where there any quality issues noted prior to the packaging being handled? in some instances the packaging looks wrinkled or as if it had been compressed or crushed.Other times the packaging looks to be in good order and then the staff would find micro holes in the packaging after the item was opened to the sterile field.Was the outer case that the package arrived in damaged? the outside packaging/master pack often appears to be in good order with no obvious signs of damage.Was the packaging torn prior to opening of the package? no, the item was not torn where did you receive the product from (ethicon, distributor, etc)? not sure.Will the device be returned? if yes, to whom should a shipper kit be sent to? please include full name and address.Na.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.What is the lot number? are there samples available to be returned for evaluation? event related to mw # 2210968-2021-07757, mw # 2210968-2021-07758, mw # 2210968-2021-07759, mw # 2210968-2021-07760, mw # 2210968-2021-07762.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 a patient underwent an unknown procedure on unknown date and suture was used.Micro holes were observed on the product wrappers, even when pulled from the factory master package.Some of the packages look brand new and have a couple micro holes in the wrappers.The facility has moved to having the boxes outside or to minimize potential for foil to be torn.The facility has also claimed they have found micro-leaks.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: 0 ENDOLOOP LIG W/PDS II
• Type of Device: CANNULA, SURGICAL, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente; dutra, km 154; sao paolo 12240 -908; BR 12240-908
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12375612
• MDR Text Key: 268518328
• Report Number: 2210968-2021-07761
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10705031206427
• UDI-Public: 10705031206427
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K843187
• 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
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EZ10G
• Device Catalogue Number: EZ10G
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1