FDA Adverse Event Injury Summary report: N

ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN)

MDR report key: 8621355 · Received May 17, 2019

Report

Report Number: 3005075853-2019-19210
Event Type: Injury
Date Received: May 17, 2019
Report Date: April 25, 2019
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GCJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NC
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT COMPLAINT #: (B)(4). DATE OF EVENT: UNKNOWN. BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. 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. IS THE PRODUCT CODE AND LOT NUMBER OF THE DEVICE AVAILABLE? WHAT WERE THE INDICATIONS FOR SURGERY? WHAT SPECIFIC SURGICAL PROCEDURE WAS PERFORMED? WAS A LEAK TEST PERFORMED IN THE INITIAL SURGICAL PROCEDURE? IF SO, WHAT WAS THE RESULT? HOW MANY DAYS POSTOPERATIVE DID THE LEAK OCCUR? HOW WAS LEAK IDENTIFIED? HOW WAS THE LEAK ADDRESSED? WERE THERE ANY ISSUES NOTED WITH STAPLE FORMATION AT ANY POINT THROUGHOUT THE CARE OF THE PATIENT? WHY DOES THE SURGEON BELIEVE THE EVENT WAS ¿MOST LIKELY ASSOCIATED WITH THE STAPLER OR ERROR IN USE WITH THE STAPLER¿? WHAT IS THE CURRENT STATUS OF THE PATIENT?

Description of Event or Problem · 1

IT WAS REPORTED BY THE SURGEON THAT FOLLOWING A COLON PROCEDURE, THE PATIENT EXPERIENCED A POST-OPERATIVE LEAK. THERE WERE NO ISSUES IDENTIFIED INTRAOPERATIVELY. IT IS UNKNOWN HOW THE LEAK WAS ADDRESSED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
413551	ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN)	LAPAROSCOPE, GENERAL AND PLASTIC SURGERY	GCJ	ETHICON ENDO-SURGERY, LLC.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention