ENDOPATH** XCEL* TROCAR

MDR report key: 2073069 · Received April 29, 2011

Report

Report Number: 3005075853-2011-01798
Event Type: Malfunction
Date Received: April 29, 2011
Date of Event: April 12, 2011
Report Date: April 12, 2011
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: VA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4) AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

Additional Manufacturer Narrative · 1

(B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD CONDITION. UPON EVALUATION OF THE DEVICE, THE DUCKBILL WAS FOUND TO BE SLIGHTLY OPEN AT SLIT. A LEAK TEST WAS PERFORMED AND THE DEVICE WAS NOTED TO LEAK WITHOUT THE TEST PROBE INSERTED THROUGH THE DEVICE. A POTENTIAL CAUSE OF THIS FAILURE IS ATTRIBUTED TO MOLDING, COMPONENT TRANSIT, BODILY FLUIDS OR DEBRIS FROM SURGERY. AS EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING THE MANUFACTURING PROCESS, NO CONCLUSION COULD BE REACHED AS TO WHAT MIGHT HAVE CAUSED THE REPORTED EVENT. HOWEVER, AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE INSUFFLATIONS ISSUES. THE FINAL QUALITY RELEASE CRITERIA WERE MET BEFORE THIS BATCH WAS RELEASED FOR DISTRIBUTION.

Additional Manufacturer Narrative · 1

(B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A LAPAROSCOPIC RIGHT COLECTOMY PROCEDURE, THE TROCAR HAD INSUFFLATIONS ISSUES WHEN A DEVICE WAS IN THE TROCAR. THEY USED THE DEVICE TO COMPLETE THE PROCEDURE BUT IT WAS A NUISANCE TO THE SURGEON.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOPATH** XCEL* TROCAR	LAPAROSCOPE, GENERAL AND PLASTIC SURGERY	GCJ	ETHICON ENDO-SURGERY, LLC.	NA	G4U57R

Patients

Seq	Age	Sex	Outcome	Treatment
1				RF DEVICE