SIDEFIBER * SF-980-DL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-09-12 for SIDEFIBER * SF-980-DL manufactured by Biolitec, Inc.

Event Text Entries

[951799] Patient undergoing cystoscopy with laser photo vaporization of the prostate. During procedure laser tip broke inside the bladder. The tip was retrieved intact with the use of a zero-tip basket. The operation then continued with a new laser fiber. When the basket was returned to the tech it was noted that the basket was intact but could not be extended.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1174972
• MDR Report Key: 1174972
• Date Received: 2008-09-12
• Date of Report: 2008-09-12
• Date of Event: 2008-06-18
• Report Date: 2008-09-12
• Date Reported to FDA: 2008-09-12
• Date Added to Maude: 2008-09-28
• 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: SIDEFIBER
• Generic Name: FIBER, LASER, ENDOSCOPIC
• Product Code: LNK
• Date Received: 2008-09-12
• Model Number: *
• Catalog Number: SF-980-DL
• Lot Number: E08-0261-B
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: N
• Device Age: 1 DY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 1202206
• Manufacturer: BIOLITEC, INC
• Manufacturer Address: 515 SHAKER ROAD EAST LONGMEADOW MA 01028 US

Device Sequence Number: 2

• Brand Name: ZERO-TIP BASKET
• Generic Name: STONE RETRIEVAL BASKET
• Product Code: FFL
• Date Received: 2008-09-12
• Model Number: *
• Catalog Number: M006 3901050
• Lot Number: 11410953
• ID Number: *
• Device Availability: N
• Device Age: 1 DY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 1202207
• Manufacturer: BOSTON SCIENTIFIC CORP.
• Manufacturer Address: ONE BOSTON SCIENTIFIC PLACE NATICK MA 01760 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2008-09-12