MORCELLATOR AND MORCELLATOR BAG * 410010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-12-13 for MORCELLATOR AND MORCELLATOR BAG * 410010 manufactured by Cook Urological Inc..

Event Text Entries

[17906212] In 1998, pt underwent laparoscopic splenectomy surgery. This surgery was to involve the internal separation of spleen, the internal placement of the same in a morcellator bag and the removal of the bag (with the emulsified contents) through an incision. The entire procedure was to be observed by the physicians and staff through the use of a laparoscope inserted through another incision. During the procedure, the morcellator penetrated the morcellator bag. Rather than halting the procedure at that point, the dr continued morcellation, causing injuries to colon, pancreas, diaphragm, and kidney. Due to these injuries to colon, certain materials spilled into abdominal cavity, infecting internal organs (peritonitis). There were numerous complications leading to infection in lungs as well, which subsequently required the placement of a drainage tube. Later that month, incision was finally closed, since add'l exposure would lead to a drying of the perforation of bowels. Pt died four days later.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1020662
• MDR Report Key: 309586
• Date Received: 2000-12-13
• Date of Event: 1998-10-01
• Date Added to Maude: 2000-12-27
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: MORCELLATOR AND MORCELLATOR BAG
• Generic Name: MORCELLATOR BODY ASSEMBLY SERIES #1
• Product Code: LEC
• Date Received: 2000-12-13
• Model Number: *
• Catalog Number: 410010
• Lot Number: J-CTM-410010
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 299530
• Manufacturer: COOK UROLOGICAL INC.
• Manufacturer Address: 1100 WEST MORGAN ST PO BOX 227 SPENCER IN 47460 US

Device Sequence Number: 2

• Brand Name: MORCELLATOR AND MORCELLATOR BAG
• Generic Name: LAP SAC SURGICAL TISSUE POUCH
• Product Code: LEC
• Date Received: 2000-12-13
• Model Number: *
• Catalog Number: 054XXX
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 299532
• Manufacturer: COOK UROLOGICAL INC.
• Manufacturer Address: 1100 WEST MORGAN ST PO BOX 227 SPENCER IN 47460 US

Device Sequence Number: 3

• Brand Name: MORCELLATOR AND MORCELLATOR BAG
• Generic Name: MORCELLATOR BODY ASSEMBLY SERIES #2
• Product Code: LEC
• Date Received: 2000-12-13
• Model Number: *
• Catalog Number: 410010
• Lot Number: J-CTM-410010
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 299534
• Manufacturer: COOK UROLOGICAL INC.
• Manufacturer Address: 1100 WEST MORGAN ST PO BOX 227 SPENCER IN 47460 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death; 2. Hospitalization; 3. Life Threatening; 4. Required No Informationntervention	2000-12-13