MAUDE Adverse Event Report: APPLIED MEDICAL KII SHIELDED BLADED ACCESS SYSTEM 12 X 100 MM; SHIELDED/BLADED/OBTURATUR W/ADVANCED FIXATION SLEEVE 12/100 MM. #4 UNIQUE IDENTI

Model Number REF CFB73

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Exsanguination (1841); Laceration(s) (1946)

Event Date 08/11/2015

Event Type  Death  

Event Description

Laparoscopic ovarian cystectomy procedure, robotic assisted.A 12 mm trocar sleeve advanced into abdomen through a 12 mm incision.After entry into abdominal cavity, large amount of blood accumulation noted.A second incision was made and 5 mm trocar sleeve advanced to allow irrigator and evacuation of blood.An emergent exploratory laparotomy occurred revealing large amount of blood in abdomen.Vascular surgery was called and immediately available.Attempted repair and resuscitation were unsuccessful.Postmortem exam revealed puncture wound through right common iliac artery and portion of large intestine.Common device name.: shielded bladed obturator w/advanced fixation sleeve 12/100 mm.Approximate age of device.: device new, sterile, one-time usage.Expiration 08/03/2015.

• Brand Name: KII SHIELDED BLADED ACCESS SYSTEM 12 X 100 MM
• Type of Device: SHIELDED/BLADED/OBTURATUR W/ADVANCED FIXATION SLEEVE 12/100 MM. #4 UNIQUE IDENTI
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5152210
• MDR Text Key: 28452064
• Report Number: 5152210
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117634
• UDI-Public: (01)00607915117634(17)180405(30)01(10)1243751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/06/2015,10/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/03/2017
• Device Model Number: REF CFB73
• Device Lot Number: 1228719
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2015
• Distributor Facility Aware Date: 09/29/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 25 YR
• Patient Weight: 56