VERESS PNEUMO NEEDLE EXEL-DR PNEUMO NEEDLE RPN 120

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-08-17 for VERESS PNEUMO NEEDLE EXEL-DR PNEUMO NEEDLE RPN 120 manufactured by Imagyn Medical Technologies.

Event Text Entries

[15741249] Pt admitted for laparoscopic cholecystectomy. 150mm disposable pneumo-needle was used with a 120mm reusable pneumo needle body, sharp needle protruded instead of blunt end.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 291190
• MDR Report Key: 291190
• Date Received: 2000-08-17
• Date of Report: 2000-08-16
• Date of Event: 2000-07-14
• Date Facility Aware: 2000-08-10
• Report Date: 2000-08-16
• Date Reported to FDA: 2000-08-16
• Date Reported to Mfgr: 2000-08-16
• Date Added to Maude: 2000-08-22
• 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 Sequence Number: 1

• Brand Name: VERESS PNEUMO NEEDLE
• Generic Name: VERESS PNEUMO NEEDLE
• Product Code: FHO
• Date Received: 2000-08-17
• Model Number: EXEL-DR PNEUMO NEEDLE
• Catalog Number: RPN 120
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 281837
• Manufacturer: IMAGYN MEDICAL TECHNOLOGIES
• Manufacturer Address: 3050 REDHILL AVE COSTA MESA CA 92626 US

Device Sequence Number: 2

• Brand Name: VERESS PNEUMO NEEDLE DETACH A TIP
• Generic Name: PNEUMO NEEDLE
• Product Code: FHO
• Date Received: 2000-08-17
• Model Number: DETACHA TIP
• Catalog Number: DPN 150
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 281840
• Manufacturer: MICRO SURGE INC
• Manufacturer Address: 150 A STREET NEEDHAM MA 02194 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death; 2. Hospitalization; 3. Required No Informationntervention	2000-08-17