CO2 LASER, SHARPLAN 1075 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-26 for CO2 LASER, SHARPLAN 1075 * manufactured by Sharplan Laser, Inc..

Event Text Entries

[42423] During a surgical procedure involving bilateral salpingostomies and lysis of pelvic adhesions, the co2 laser continued to fire after the pedal was no longer depressed. There was no pt injury. Distributor notified.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 65320
• MDR Report Key: 65320
• Date Received: 1996-07-26
• Date of Report: 1996-07-26
• Date of Event: 1996-07-19
• Date Facility Aware: 1996-07-19
• Report Date: 1996-07-26
• Date Added to Maude: 1997-01-30
• 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: CO2 LASER, SHARPLAN
• Generic Name: SAME
• Product Code: HHR
• Date Received: 1996-07-26
• Model Number: 1075
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 12 MO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 65414
• Manufacturer: SHARPLAN LASER, INC.
• Manufacturer Address: 33 OKAB WAT WARWICK RI 02886 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1996-07-26