N/A 9S-5602

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-09-02 for N/A 9S-5602 manufactured by Surgimedics.

Event Text Entries

[15614852] Devices - yag laser, laser fiberduring an arthoscopic procedure, the tip of a laser fiber broke off in the patient's knee. Several attempts were made to retreive the tip, but efforts were unsuccessful. X-rays were taken with negative results. It was determined that the tip is possibly in the soft tissuedevice labeled for single use. Patient medical status prior to event: fair condition. There was not 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. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: other. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3013
• MDR Report Key: 3013
• Date Received: 1992-09-02
• Date of Report: 1992-02-13
• Date of Event: 1992-01-29
• Date Facility Aware: 1992-01-29
• Report Date: 1992-02-13
• Date Reported to Mfgr: 1992-01-29
• Date Added to Maude: 1993-04-05
• 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

• Generic Name: LASER FIBER
• Product Code: LWX
• Date Received: 1992-09-02
• Model Number: N/A
• Catalog Number: 9S-5602
• Lot Number: 080000
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2816
• Manufacturer: SURGIMEDICS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-09-02