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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-18 for * manufactured by Gyrus Medical, Inc..

Event Text Entries

[1163734] Procedure - cystolithopaxy with holmium laser. 1000 micron fiber(acmi lot# d2707s exp 2010-07) was opened and laser beam had a crisp circle- when placed through the 23fr continuous flow cystoscope, the fiber appeared to be cracked. This fiber was replaced with another 1000 (acmi lot# d2908s exp 2011-07) and this appeared to have a slight crack - it functioned without any problems. After a short time, the tip broke off. The beam looked fine and the md continued to use this fiber. Md requested to use a 600- micron fiber (acmi lot#c2808s exp 2011-07). This fiber appeared to shed its outer coating of the fiber itself- not the insulation. This fiber was replaced with another 600 fiber and that fiber was used for the remainder of the case. The fiber was passed through a cook check-flo adaptor that has an id of <= 9. 0 fr which accomodates the 1000 micron fiber.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1405640
• MDR Report Key: 1405640
• Date Received: 2009-06-18
• Date of Report: 2009-06-05
• Date of Event: 2009-06-04
• Report Date: 2009-06-05
• Date Reported to FDA: 2009-06-18
• Date Added to Maude: 2009-06-24
• 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
• 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 Sequence Number: 1

• Brand Name: *
• Generic Name: LASER FIBER, 1000 MICRON
• Product Code: LNK
• Date Received: 2009-06-18
• Model Number: *
• Catalog Number: *
• Lot Number: LD2707S
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GYRUS MEDICAL, INC.
• Manufacturer Address: 6655 WEDGEWOOD ROAD, SUITE 160 MAPLE GROVE MN 55311360 US 55311 3602

Device Sequence Number: 2

• Brand Name: *
• Generic Name: LASER FIBER, 1000 MICRON
• Product Code: LNK
• Date Received: 2009-06-18
• Model Number: *
• Catalog Number: *
• Lot Number: D2808S
• ID Number: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: GYRUS MEDICAL, INC.
• Manufacturer Address: * * *

Device Sequence Number: 3

• Brand Name: *
• Generic Name: LASER FIBER, 600 MICRON
• Product Code: LNK
• Date Received: 2009-06-18
• Model Number: *
• Catalog Number: *
• Lot Number: C2808S
• ID Number: *
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: GYRUS MEDICAL, INC.
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2009-06-18