ULTRASONIC PROBE 27093LL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-06-20 for ULTRASONIC PROBE 27093LL manufactured by Karl Storz Gmbh & Co..

Event Text Entries

[4668430] Allegedly, while performing a stone fragmentation procedure, the tip of the probe came off into patient. Doctor immediately retrieved. Procedure was completed with no injury to patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9610617-2014-00032
• MDR Report Key: 3925159
• Report Source: 05,06
• Date Received: 2014-06-20
• Date of Report: 2014-06-20
• Date of Event: 2014-03-26
• Date Added to Maude: 2014-07-24
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: SUSIE CHEN
• Manufacturer Street: 2151 E. GRAND AVENUE
• Manufacturer City: EL SEGUNDO CA 902455017
• Manufacturer Country: US
• Manufacturer Postal: 902455017
• Manufacturer Phone: 4242188201
• Manufacturer G1: KARL STORZ GMBH & CO. KG
• Manufacturer Street: MITTELSTRASSE 8
• Manufacturer City: TUTTLINGEN 78503
• Manufacturer Country: GM
• Manufacturer Postal Code: 78503
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ULTRASONIC PROBE
• Generic Name: ULTRASONIC PROBE
• Product Code: FEO
• Date Received: 2014-06-20
• Model Number: 27093LL
• Catalog Number: 27093LL
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: KARL STORZ GMBH & CO.
• Manufacturer Address: TUTTLINGEN GM

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2014-06-20