FDA Adverse Event Injury Summary report: N

PROXIMATE*ILS CURVED CIR STAPL

MDR report key: 1832555 · Received September 13, 2010

Report

Report Number: 3005075853-2010-05229
Event Type: Injury
Date Received: September 13, 2010
Date of Event: August 18, 2010
Report Date: August 19, 2010
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GDW
PMA / PMN Number: K983536
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING RESPONSE WAS RECEIVED ON 9/8/2010: (B)(6). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. IN ADDITION, THE STAPLE RETAINER WAS RECEIVED IN GOOD VISUAL CONDITIONS. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, AFTER THE FIRING, ONLY HALF CIRCLE TISSUE WAS CUT AND ANASTOMOSED. THEN THE SURGEON USED HAND COLOSTOMY TO FINISH THE PROCEDURE. NOW THE PATIENT IS FINE. THE PATIENT HAD RECTUM CANCER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PROXIMATE*ILS CURVED CIR STAPL	STAPLE, IMPLANTABLE	GDW	ETHICON ENDO-SURGERY, LLC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	76 YR		Other\| R