FDA Adverse Event Malfunction Summary report: N

GST GREEN RELOAD, 60MM, 6 ROW

MDR report key: 17363291 · Received July 20, 2023

Report

Report Number: 3005075853-2023-05128
Event Type: Malfunction
Date Received: July 20, 2023
Date of Event: June 13, 2023
Report Date: July 20, 2023
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GDW
UDI-DI: 10705036014713
PMA / PMN Number: K110385
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

(B)(4). DATE SENT: 7/20/2023. D4: BATCH # UNK. INVESTIGATION SUMMARY : THIS IS AN ANALYSIS OF THE PHOTOS SUBMITTED TO ETHICON ENDO-SURGERY FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTOS SHOW A TYVEK WITH PRODUCT CODE GST60G, LOT # T42G40, EXP. DATE: 20226-09-30. THERE WERE NUMEROUS DISCREPANCIES FOUND WHEN COMPARING THE SUSPECT PACKAGES AND THE AUTHENTIC SUPPLIER PACKAGING/AUTHENTIC ARTWORK. THE LOT NUMBERS AND EXPIRATION DATES ON THE SUSPECT PACKAGES DOES NOT MATCH INFORMATION IN OUR J&J SYSTEMS. THE EVALUATION PERFORMED DETERMINED THAT ALL THE SUSPECT PACKAGES LISTED ABOVE IS COUNTERFEIT AND NOT AUTHENTIC ETHICON/JOHNSON & JOHNSON MEDICAL DEVICE PRODUCTS. BASED ON THE PHOTOS REVIEWED, THE COUNTERFEIT PRODUCT IS CONFIRMED.

Description of Event or Problem · 0

IT WAS REPORTED THAT THEY CONDUCTED A TEST PURCHASE THAT RESULTED IN 192 UNITS OF ECHELON RELOADS THAT BORE COUNTERFEIT FEATURES ON THE PACKAGING. THESE PRODUCTS HAVE BEEN SENT TO CINCINNATI FOR FURTHER ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
37998	GST GREEN RELOAD, 60MM, 6 ROW	STAPLE, IMPLANTABLE	GDW	ETHICON ENDO-SURGERY, LLC.	GST60G	T42G40	10705036014713

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown