RADICAL JAW DIAPOSABLE 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 1993-01-29 for RADICAL JAW DIAPOSABLE BIOPSY FORCEPS 1266 manufactured by Microvasive.

Event Text Entries

[1745] Patient was undergoing a local flexible bronchoscopy and physician was attempting to obtain a biopsy using the equipment in question. The first attempt was unsuccessful and a second attempt was made. During that second attempt, a loud snap was heard and the tension on the forcep was gone. The bronchoscope was removed with the forceps still inside. The forcep was removed with difficulty from the bronchoscope and the biopsy cups were missing from the cap. X-rays was performed of the bronchoscope and the missing biopsy forcep cups were found in the suction port of the bronchoscope. The patient suffered no adverse effects from this incident. Evaluation of the forceps appeared to show device failure of the internal mechanismdevice 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, visual examination. Results of evaluation: component failure. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2330
• MDR Report Key: 2330
• Date Received: 1993-01-29
• Date of Report: 1993-01-06
• Date of Event: 1992-12-31
• Date Facility Aware: 1992-12-31
• Report Date: 1993-01-06
• Date Reported to FDA: 1993-01-06
• Date Reported to Mfgr: 1993-01-06
• Date Added to Maude: 1993-02-04
• 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: RADICAL JAW DIAPOSABLE BIOPSY FORCEPS
• Generic Name: N/A
• Product Code: BWH
• Date Received: 1993-01-29
• Model Number: 1266
• Catalog Number: 1266
• Lot Number: 2070845A
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2156
• Manufacturer: MICROVASIVE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-01-29