FDA Adverse Event Malfunction Summary report: N

ENDOPATH** XCEL* BLADELESS TROCAR WITH STABILITY SLEEVE

MDR report key: 1812294 · Received August 24, 2010

Report

Report Number: 3005075853-2010-04814
Event Type: Malfunction
Date Received: August 24, 2010
Date of Event: July 28, 2010
Report Date: July 28, 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 Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). OBTURATOR INSERTED THROUGH THE SLEEVE, DAMAGED UNIVERSAL SEAL ASSEMBLY THE ANALYSIS RESULTS OF THE (B)(4) FOUND THAT IT WAS RECEIVED WITH THE OBTURATOR INSERTED THROUGH THE SLEEVE AND WITH THE CAPE AND BASE OF THE UNIVERSAL SEAL ASSEMBLY SEPARATED. EVIDENCES OF WELDING WERE FOUND ON THE CAPE-BASE ASSEMBLY AREA. A POTENTIAL CAUSE OF THIS CONDITION IS THE REPEATED USE OF ETO AS A STERILIZATION AGENT. EES SINGLE-USE TROCARS ARE NOT TO BE REUSED, REPROCESSED OR RE-STERILIZED. THESE FINDINGS ARE NOT RELATED TO THE INCIDENT REPORTED. THE DISTAL TIP OF THE SLEEVE AND THE LENS OF THE OBTURATOR WERE NOTED IN GOOD CONDITION. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

Additional Manufacturer Narrative · 1

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

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TRANSITION TIP OF THE TROCAR BROKE INTO THE TWO PARTS WHEN THE SURGEON PULLED IT OUT. THE CORE HAD THE CRACK. 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* BLADELESS TROCAR WITH STABILITY SLEEVE	LAPAROSCOPE, GENERAL AND PLASTIC SURGERY	GCJ	ETHICON ENDO-SURGERY, LLC.	UNK	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1