DEXIDE * 10/11 TROCAR #245-10

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-06-25 for DEXIDE * 10/11 TROCAR #245-10 manufactured by Dexide Inc..

Event Text Entries

[99242] Surgeon was starting a laparoscopic cholecystectomy in the usual manner. A pneumoperitoneum needle was inserted and then reinserted due to resistance. The pneumoperitoneum needle was tested with a needle saline drop technique which appeared to be adequate. Carbon dioxide was then insufflated, and having insufflated, a ten dexide trocar was inserted and camera instilled. Three remaining trocars were placed, one ten and two fives, after which bleeding was observed in the right upper quadrant. The abdomen was immediately opened and appropriate surgial interventions were made to repair the aorta and left iliac artery. The pt did survive, has gone home and to date, has gone back to work.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 174711
• MDR Report Key: 174711
• Date Received: 1998-06-25
• Date of Report: 1998-06-24
• Date of Event: 1998-04-23
• Date Facility Aware: 1998-04-23
• Report Date: 1998-06-24
• Date Reported to Mfgr: 1998-06-24
• Date Added to Maude: 1998-07-01
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: DEXIDE
• Generic Name: SURGICAL TROCAR AND PNEUMO NEEDLE
• Product Code: GCJ
• Date Received: 1998-06-25
• Model Number: *
• Catalog Number: 10/11 TROCAR #245-10
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 169869
• Manufacturer: DEXIDE INC.
• Manufacturer Address: 7509 FLAGSTONE ST. FORT WORTH TX 76118 US

Device Sequence Number: 2

• Brand Name: DEXIDE
• Generic Name: SURGICAL TROCAR AND PNEUMO NEEDLE
• Product Code: FHP
• Date Received: 1998-06-25
• Model Number: *
• Catalog Number: PNEUMO NEEDLE #210-12
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 169872
• Manufacturer: DEXIDE INC.
• Manufacturer Address: 7509 FLAGSTONE ST. FORT WORTH TX 76118 US

Device Sequence Number: 3

• Brand Name: DEXIDE
• Generic Name: SURGICAL TROCAR AND PNEUMO NEEDLE
• Product Code: GCJ
• Date Received: 1998-06-25
• Model Number: *
• Catalog Number: 5.5 TROCAR #245-06
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 3
• Device Event Key: 169874
• Manufacturer: DEXIDE INC.
• Manufacturer Address: 7509 FLAGSTONE ST. FORT WORTH TX 76118 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention	1998-06-25