LASERSONICS 8900

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-27 for LASERSONICS 8900 manufactured by Heraeus Laser Sonics.

Event Text Entries

[18337843] Foot pedal on yag laser became non-functional during surgical case, after cervical incision bleeding could not be stopped using laser. Physician utilized stitches instead. Patient last 600 cc blood, and will if possibly require additional care. Manufacturer/service representation contacted and new foot pedal sent. When installed, device worked. Utmb biomedical engineering and electronics inspected foot pedal, finding that an internal wire had disconnected from a switch. There was inadequate strain relief on the wire which was ibe if several leading to the cord. 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-feb-92. Service provided by: manufacturer. Service records not 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. Results of evaluation: foot switch. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device discarded. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3785
• MDR Report Key: 3785
• Date Received: 1992-07-27
• Date of Report: 1992-03-12
• Date of Event: 1991-02-28
• Date Facility Aware: 1991-02-28
• Report Date: 1992-03-12
• Date Reported to Mfgr: 1992-03-04
• Date Added to Maude: 1993-05-05
• 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: LASERSONICS
• Generic Name: YAG LASER 150 WATT
• Product Code: LLO
• Date Received: 1992-07-27
• Model Number: 8900
• Lot Number: N/A
• ID Number: INVENTORY #160534
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-SEP-88
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3528
• Manufacturer: HERAEUS LASER SONICS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-27