FDA Adverse Event Malfunction Summary report: N

75MM SELECTABLE NEW TLC

MDR report key: 2010455 · Received March 8, 2011

Report

Report Number: 3005075853-2011-00934
Event Type: Malfunction
Date Received: March 8, 2011
Date of Event: February 9, 2011
Report Date: February 11, 2011
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GDW
PMA / PMN Number: K092577
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). SWING TAB IN LOCKED POSITION. THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A CARTRIDGE RELOAD LOADED IN THE INSTRUMENT. THE CARTRIDGE RELOAD HAD THE SWING TAB IN THE LOCKED POSITION, AND THE PROXIMAL ONE DRIVER UP AND THE REMAINING DRIVERS WERE DOWN WITH STAPLES PRESENT. IT COULD NOT BE DETERMINED IF THE REPORTED INCIDENT WAS THE RESULT OF A PREMATURE LOCKOUT, OR THE RESULT OF AN INTERRUPTED FIRING STROKE. THE SWING TAB WAS RESET AND THEN THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED CARTRIDGE RELOAD AND IT PERFORMED AS INTENDED. THE DEVICE CLOSED WITHOUT ANY DIFFICULTIES NOTED. WHILE NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT, IT SHOULD BE NOTED THAT 100% INSPECTION IS PERFORMED BY MEANS OF (B)(4) TO INSURE THE SWING TAB IS PRESENT AND UNLOCKED. 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 SIGMOIDECTOMY PROCEDURE, ON THE STAPLE LINE CLOSEST TO THE KNIFE AT THE PROXIMAL END ON THE PATIENT SIDE, THE STAPLES WERE NOT FORMED CORRECTLY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	75MM SELECTABLE NEW TLC	STAPLE, IMPLANTABLE	GDW	ETHICON ENDO-SURGERY, LLC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1				CARTRIDGE