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).Event related to mw # 2210968-2021-07757, mw # 2210968-2021-07759, mw # 2210968-2021-07760, mw # 2210968-2021-07761, mw # 2210968-2021-07762.

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: 12375592
• MDR Text Key: 268516039
• Report Number: 2210968-2021-07758
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10705031206427
• UDI-Public: 10705031206427
• Combination Product (y/n): N
• 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