SHARPLAN 1100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for SHARPLAN 1100 manufactured by Sharplan Laser Inc..

Event Text Entries

[18825815] During surgery the yag laser failed to provide proper power output. Power as increased from 60 to 80 watts without effect. The fiber was changed without effect. The laser option was abandoned and the prostate was incised with electrosurgery. This was not the method of choice because of the patient's pre-existing condition. Invalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9252
• MDR Report Key: 9252
• Date Received: 1994-07-29
• Date of Report: 1994-07-15
• Report Date: 1994-07-15
• Date Added to Maude: 1994-12-06
• 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: 0
• Initial Report to FDA: 0
• 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: SHARPLAN
• Generic Name: LASER
• Product Code: LLO
• Date Received: 1994-07-29
• Model Number: 1100
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 8910
• Manufacturer: SHARPLAN LASER INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. No Informationnvalid Deathata	1994-07-29