NEOPROBE ETHICON PROBE NPR 14 (1017) *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-09-04 for NEOPROBE ETHICON PROBE NPR 14 (1017) * manufactured by Ethicon Endosurgery Inc..

Event Text Entries

[233595] Head of neoprobe disconnected from probe inside patient's chest cavity. It was determined that the rubber cover broke and the 14mm tip fell off the probe into the chest cavity. The tip (collimator) was retrieved by md. Follow up action: information was shared regarding the use of the neoprobe intraoperatively and the draping of the neoprobe. The company (ethicon) was contacted regarding the tip of the probe falling off. The company representative and service leader are working on steps to prevent this from happening again.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1022770
• MDR Report Key: 350421
• Date Received: 2001-09-04
• Date of Report: 2001-08-27
• Date of Event: 2001-04-23
• Date Added to Maude: 2001-09-10
• 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: RISK MANAGER
• 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: NEOPROBE ETHICON
• Generic Name: PROBE
• Product Code: IZD
• Date Received: 2001-09-04
• Model Number: PROBE NPR 14 (1017)
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 339716
• Manufacturer: ETHICON ENDOSURGERY INC.
• Manufacturer Address: 4545 CREEK ROAD CINCINNATTI OH 452422803 US

Device Sequence Number: 2

• Brand Name: NEOPROBE ETHICON
• Generic Name: COLLIMATOR
• Product Code: JAN
• Date Received: 2001-09-04
• Model Number: COLLIMATOR NPE14 (1013)
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 339739
• Manufacturer: ETHICON ENDOSURGERY INC
• Manufacturer Address: 4545 CREEK RD CINCINNATI OH 452422803 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2001-09-04