ENDOPATH PN150 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-28 for ENDOPATH PN150 * manufactured by Ethicon Endo-surgery, Inc..

Event Text Entries

[20518569] Pt undergoing laparoscopic cholecystectomy, upon inserting verres needle the small bowel was punctured, necessitating add'l surgery.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 537412
• MDR Report Key: 537412
• Date Received: 2004-07-28
• Date of Report: 2004-07-08
• Date of Event: 2004-07-02
• Date Facility Aware: 2004-07-07
• Report Date: 2004-07-08
• Date Reported to Mfgr: 2004-07-08
• Date Added to Maude: 2004-08-04
• 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: 3
• 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: ENDOPATH
• Generic Name: VERRES NEEDLE
• Product Code: FHP
• Date Received: 2004-07-28
• Model Number: PN150
• Catalog Number: *
• Lot Number: 2008-07
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 526660
• Manufacturer: ETHICON ENDO-SURGERY, INC.
• Manufacturer Address: 4545 CREEK RD. CINCINNATI OH 45242 US
• Baseline Brand Name: ENDOPATH PNEUMOPERITONEUM NEEDLE
• Baseline Generic Name: TROCAR ACCESSORIES
• Baseline Model No: PN150
• Baseline Catalog No: PN150
• Baseline ID: *
• Baseline Device Family: TROCAR ACCESSORIES
• Baseline Shelf Life Contained: Y
• Baseline Shelf Life [Months]: 60
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K924035
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2004-07-28