* 216710

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-10-29 for * 216710 manufactured by Richard Wolf Medical Instruments Corp..

Event Text Entries

[15005072] Numerous metal shavings found after procedure. Equipment removed for inspection.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1014865
• MDR Report Key: 194735
• Date Received: 1998-10-29
• Date of Report: 1998-10-29
• Date of Event: 1998-09-24
• Date Added to Maude: 1998-11-03
• 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 Details

• Brand Name: *
• Generic Name: NEPHROSCOPE
• Product Code: FGA
• Date Received: 1998-10-29
• Model Number: *
• Catalog Number: 216710
• Lot Number: *
• ID Number: R/A # 15446
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 189194
• Manufacturer: RICHARD WOLF MEDICAL INSTRUMENTS CORP.
• Manufacturer Address: 353 CORPORATE WOODS PKWY VERNON HILLS IL 60061 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1998-10-29