SURGIFISH *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-06-19 for SURGIFISH * manufactured by Greer Medical, Inc..

Event Text Entries

[15184864] Surgifish was used in a surgical procedure performed on a bariatric case (gastric stapling). The surgifish is a supply (piece of rubber) that is used between the viscera and an organ/vessel. The surgifish is yellow in color and did not have an attached string and ring to assist with item location in the abdominal cavity. The item was left in the pt. Because it is not radiopaque, it does not show up on x-ray. It was discovered three months later in an unrelated surgery at another hospital. The item perforated the bowel in two areas. The pt had several hosp admissions complaining of abdominal pain and nausea prior to the detection of the foreign body.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 468669
• MDR Report Key: 468669
• Date Received: 2003-06-19
• Date of Report: 2003-06-18
• Date of Event: 2003-06-04
• Date Facility Aware: 2003-06-04
• Report Date: 2003-06-18
• Date Added to Maude: 2003-07-01
• 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
• Reporter Occupation: RISK MANAGER
• 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 Details

• Brand Name: SURGIFISH
• Generic Name: VISCERA RETAINER
• Product Code: GCZ
• Date Received: 2003-06-19
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 457569
• Manufacturer: GREER MEDICAL, INC.
• Manufacturer Address: 314 E. CARRILLO STREET SANTA BARBARA CA 93101 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2003-06-19