STORZ *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-23 for STORZ * manufactured by Karl Storz Endoscopy-america Inc..

Event Text Entries

[60554] Failed attempt to break up bladder stones with electro hydraulic lithotripsy following multiple attempts due to intermittent firing problem. A storz lithotrite jaws broke apart requiring surgical opening of the bladder to remove the stone.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 99594
• MDR Report Key: 99594
• Date Received: 1997-06-23
• Date of Report: 1997-06-09
• Date of Event: 1997-05-22
• Date Reported to Mfgr: 1997-06-09
• Date Added to Maude: 1997-06-24
• 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: STORZ
• Generic Name: LITHOTRITE
• Product Code: FGK
• Date Received: 1997-06-23
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 98132
• Manufacturer: KARL STORZ ENDOSCOPY-AMERICA INC.
• Manufacturer Address: 600 CORPORATE POINT CULVER CITY CA 902307600 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-06-23