ENDOPATH** XCEL* TROCAR

MDR report key: 2123699 · Received June 14, 2011

Report

Report Number: 3005075853-2011-02415
Event Type: Malfunction
Date Received: June 14, 2011
Date of Event: May 20, 2011
Report Date: May 23, 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: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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

Additional Manufacturer Narrative · 1

(B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS FUNCTIONALLY TESTED TO DETECT ANY LEAKING ISSUES. UPON EVALUATION OF THE DEVICE, IT WAS FUNCTIONALLY LEAK TESTED AND PASSED. THE DEVICE WAS FULLY FUNCTIONAL ACCORDING TO THE MANUFACTURING REQUIREMENTS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. IN ADDITION, THE LENS OF THE OBTURATOR WAS NOTED CRACKED. THE EXPOSURE TO ETHYLENE OXIDE (EO) WHICH IS PART OF THE COMPLAINT DEVICE RETURN PROCESS MAY LEAD TO CRACK/SCRATCH LENS. PLEASE NOTE THAT THIS CONDITION IS UNRELATED WITH THE INCIDENT REPORTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, ABDOMINAL AIR LEAKED AND A BOO SOUND WAS HEARD DURING USE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

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	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1				ULTRASONIC DEVICE