LIGHT SOURCE, FIBEROPTIC 5150001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-11-11 for LIGHT SOURCE, FIBEROPTIC 5150001 manufactured by Richard Wolf.

Event Text Entries

[6095] Device utilized during laproscopic tubal ligation. The light guide was removed while the camera was still turned on and connected to the rigid scope. The camera automatically increased the light intensity to maximum and a burn was noted on the surgical drape. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-mar-93. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: mechanical tests performed, performance tests performed. Results of evaluation: design - human factors, labeling - inadequate instructions for use. Conclusion: user error contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: user education provided. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9805
• MDR Report Key: 9805
• Date Received: 1994-11-11
• Date of Report: 1994-03-23
• Date of Event: 1994-02-16
• Date Facility Aware: 1994-02-16
• Report Date: 1994-03-23
• Date Reported to Mfgr: 1994-03-23
• Date Added to Maude: 1995-01-30
• 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
• 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: LIGHT SOURCE, FIBEROPTIC
• Generic Name: LIGHT SOURCE
• Product Code: FCR
• Date Received: 1994-11-11
• Model Number: 5150001
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-MAR-93
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 9457
• Manufacturer: RICHARD WOLF

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1994-11-11