FDA Adverse Event Malfunction Summary report: N

ENDOPATH** XCEL

MDR report key: 1902229 · Received November 18, 2010

Report

Report Number: 3005075853-2010-06579
Event Type: Malfunction
Date Received: November 18, 2010
Date of Event: October 18, 2010
Report Date: October 21, 2010
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GCJ
PMA / PMN Number: K032676
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE ANALYSIS RESULTS FOUND THAT FIVE DEVICES WERE RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICES WERE FUNCTIONALLY TESTED TO DETECT ANY LEAKING ISSUES. UPON EVALUATION OF THE DEVICES, THEY WERE FUNCTIONALLY LEAK TESTED AND PASSED. THE DEVICES WERE FULLY FUNCTIONAL ACCORDING TO THE MANUFACTURING REQUIREMENTS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THESE DEVICES DO NOT HAVE OBTURATORS. THE OBTURATOR IS THE PIECE OF THE TROCAR THAT HAS THE BATCH STAMPED. NO BATCH NUMBER WAS AVAILABLE; THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SURGEON FOUND THAT THE 5MM TROCARS THAT HE WAS USING IN THE PROCEDURE WERE ALL LEAKING GAS FROM THE SEALS. THE LEAKING OCCURRED ONCE AN INSTRUMENT WAS INTRODUCED TO THE PORT. SEVERAL PORTS WERE USED AND ALL WERE REPORTED TO HAVE LEAKED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOPATH** XCEL	LAPAROSCOPE, GENERAL AND PLASTIC SURGERY	GCJ	ETHICON ENDO-SURGERY, LLC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1