RADIAL JAW BIOPSY FORCEPS 1266

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-06 for RADIAL JAW BIOPSY FORCEPS 1266 manufactured by Microvasive Corporation.

Event Text Entries

[1845] Patiewnt was undergoing fiberoptic bronchoscopy with fluoroscopy under general anesthesia. M. D. Passed forceps through scope and engaged a "bite" of tissue from within the lung. Both cusps seperated from the distal end of the forceps but remained imbedded in the tissue specimen. The remaining jawa of the forceps were used to draw the tissue in which the cusps were imbedded into the scope channel. The scope was then withdrawn from the patient without further incident. The tissue specimen was discharged distally into formalin where the two cusps were recovered by staffdevice labeled for single use. Patient medical status prior to event: satisfactory 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. 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: component failure. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: other, none or unknown. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2660
• MDR Report Key: 2660
• Date Received: 1993-01-06
• Date of Report: 1992-08-05
• Date of Event: 1992-07-22
• Date Facility Aware: 1992-07-22
• Report Date: 1992-08-05
• Date Reported to Mfgr: 1992-07-24
• Date Added to Maude: 1993-03-23
• 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: RADIAL JAW BIOPSY FORCEPS
• Generic Name: DISPOSABLE BRONCHOSCOPIC BIOSPY FORCEPS
• Product Code: BWH
• Date Received: 1993-01-06
• Model Number: 1266
• Catalog Number: 1266
• Lot Number: 2012842A
• ID Number: NONE
• Device Expiration Date: 1993-01-01
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2485
• Manufacturer: MICROVASIVE CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-01-06