11X100MM KII THREADED SHIELDED BALDED ACCESS SYSTEM

Report

Report Number: 2027111-2008-00059
Event Type: Injury
Date Received: November 25, 2008
Date of Event: October 27, 2008
Report Date: November 25, 2008
Manufacturer: APPLIED MEDICAL RESOURCES
Product Code: GCJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION SUMMARY: THE RETURNED DEVICE WAS INSPECTED AND FOUND TO OPERATE AS DESIGNED. THE CUSTOMER EXPERIENCE REPORT DESCRIBES HOW THE SURGEON HAD TO TAKE UNUSUAL STEPS IN HER ATTEMPT TO PENETRATE THE PERITONEUM AND WAS ULTIMATELY UNSUCCESSFUL. THE BLADDER WAS LIKELY PUNCTURED DURING THESE MANEUVERS. THE PRODUCT INFO DATA SHEET SUPPLIED WITH THE KII SYSTEM CONTAINS A WARNING THAT THE "OBTURATOR TIP IS POINTING AWAY FROM MAJOR VESSELS, ORGANS AND OTHER ANATOMIC STRUCTURES." AS WITH ALL MEDICAL DEVICES, MFR INSTRUCTIONS SHOULD ALWAYS BE FOLLOWED CAREFULLY AND CLOSELY TO ENSURE THE SAFETY OF THE PATIENT AND THAT PRODUCT(S) PERFORM AS DESIGNED. THIS DOCUMENT REPRESENTS OUR INITIAL AND FINAL REPORT.

Description of Event or Problem · 1

"DR INSERTED THE 11MM BLADED TROCAR (KII) ON HER SECOND TROCAR ENTRY IN THE LOWER ABDOMINAL REGION (SYMPHIS PUBIS). DIFFICULTY CAME WHEN TRYING THE PENETRATE THRU THE PERITONEUM AS IT WAS LOOSE AND HANGING DOWN. AFTER REPEATED ATTEMPTS TO COME COMPLETELY THRU, A GRASPER WAS INSERTED IN THE OPERATIVE SCOPE TO RETRACT THE PERITONEUM ON THE CANNULA/TROCAR. THIS WAS NOT SUCCESSFUL. THE URINE SPECIMEN BAG WAS INFLATED AND IT WAS THEN DETERMINED THE BLADDER WAS INJURED. A UROLOGIST WAS SUMMONED AND THE BLADDER WAS REPAIRED IN THE TRADITIONAL FASHION, I.E. OPEN SURGERY. UNABLE TO LEARN OF PATIENT'S CONDITION FOLLOWING SURGERY."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	11X100MM KII THREADED SHIELDED BALDED ACCESS SYSTEM	NONE	GCJ	APPLIED MEDICAL RESOURCES	C0R63	1067038

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R