SHARPLAN 3100 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-21 for SHARPLAN 3100 * manufactured by Esc Sharplan.

Event Text Entries

[362883] Sharplan yag laser #3100 was brought into the operating room. Standard pre-patient safety test of the laser was done, with laser functioning. Intra-operatively, the laser did not generate any power and the yellow beam on the unit was flashing. However, the display mode did not indicate any malfunction. Physician commented that "it doesn't sound right. . . It shouldn't be hissing. " the sharplan device was turned off and disconnected from the power source. The slt yag laser unit was brought in, connected, and turned on but the display panel did not light up. Therefore, directions were unable to be followed. The laser procedure was cancelled; manual biopsies of bronchial mass via bronchoscope were performed. Attempted to contact vendor using number on the sharplan unit. No emergency after hours was indicated on the voicemail and no operator answered.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 547762
• MDR Report Key: 547762
• Date Received: 2004-09-21
• Date of Report: 2004-09-21
• Date of Event: 2004-09-20
• Report Date: 2004-09-21
• Date Reported to FDA: 2004-09-21
• Date Added to Maude: 2004-10-12
• 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: 3
• 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: SHARPLAN
• Generic Name: YAG LASER
• Product Code: LLO
• Date Received: 2004-09-21
• Model Number: 3100
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 537191
• Manufacturer: ESC SHARPLAN
• Manufacturer Address: 100 MORSE STREET NORWOOD MA 02062 US

Device Sequence Number: 2

• Brand Name: *
• Generic Name: SLT YAG LASER
• Product Code: LLO
• Date Received: 2004-09-21
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 537192
• Manufacturer: EXCIM
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-09-21