MICROVASIVE N/A 1266

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-01-07 for MICROVASIVE N/A 1266 manufactured by Boston Scientific Corporation.

Event Text Entries

[111] Additional equipment- pentex pediatric bronchoscope. Fb 15h sn841170 biopsy of lung- forceps checked and operating ok prior to procedure. Operated ok for 1-2 biopsys, on 3rd or 4th "bite" jaws would not close. Device and scope removed together. Jaws cut from lead, remove rest of device from scope. No damage to scope. Physician to ld patient re;occurance, all pieces accounted for. X-ray negative. Distributer representative notified 12/11/91. Charles warich 1/10 so. Elizabeth st. , denver, co 8021device 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. 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, other, other, invalid data. Results of evaluation: invalid data, invalid data, invalid data. Conclusion: device failed during assembly. Certainty of device as cause of or contributor to event: yes. Corrective actions: use of all similar devices stopped temporarily. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 124
• MDR Report Key: 124
• Date Received: 1992-01-07
• Date of Report: 1991-12-11
• Date of Event: 1991-12-10
• Date Facility Aware: 1991-12-10
• Report Date: 1991-12-11
• Date Reported to FDA: 1991-12-11
• Date Reported to Mfgr: 1991-12-11
• Date Added to Maude: 1992-03-30
• 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: MICROVASIVE
• Generic Name: RADIAL JAW DISPOSABLE BIOPSY FORCEPS
• Product Code: JEK
• Date Received: 1992-01-07
• Model Number: N/A
• Catalog Number: 1266
• Lot Number: 1087401A
• ID Number: N/A
• Device Expiration Date: 1992-08-01
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-AUG-91
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 122
• Manufacturer: BOSTON SCIENTIFIC CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-01-07