FDA Adverse Event Malfunction Summary report: N

ETS FLEX ARTICNG

MDR report key: 1821529 · Received August 31, 2010

Report

Report Number: 3005075853-2010-04962
Event Type: Malfunction
Date Received: August 31, 2010
Date of Event: June 1, 2010
Report Date: July 7, 2010
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GDW
PMA / PMN Number: K020779
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE ANALYSIS SHOWED THAT THE (B)(4) DEVICE WAS RECEIVED WITH THE ARTICULATION GEAR BROKEN OFF THE DEVICE. THE DEVICE WAS RECEIVED WITH AN UNFIRED RELOAD LOADED IN THE DEVICE. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. WHILE NO CONCLUSION COULD BE REACHED ON WHAT CAUSED THE DAMAGE ON THE ARTICULATION GEAR, IT IS POSSIBLE THAT THE DEVICE WAS ARTICULATED BEYOND ITS ARTICULATION STOP RESULTED IN THE INSTRUMENT DAMAGE. IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ANVIL RELEASE BUTTON BROKE DURING THE THIRD FIRING, THE KNOB CAME OFF AND PLASTIC WAS ON THE PATIENT BUT NOT IN THE WOUND. THEY COMPLETED THE PROCEDURE WITH A NEW LIKE DEVICE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE WILL BE RETURNING FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ETS FLEX ARTICNG	STAPLE, IMPLANTABLE	GDW	ETHICON ENDO-SURGERY, LLC.	UNK	F4P265

Patients

Seq	Age	Sex	Outcome	Treatment
1