RADIAL JAW G.I. BIOPSY FORCEP 1263

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-11-05 for RADIAL JAW G.I. BIOPSY FORCEP 1263 manufactured by Symbiosis.

Event Text Entries

[4716] This distributor became aware on 10/7/93 of a situation involving detachment of a single cup of the biospy forceps in the patient's upper gi tract. Upon removal of the forceps, attempting to obtain a second specimen in the upper gi tract, it was noted a cup had detached. Fluoroscopy revealed the detached cup remained in the patient's mucosa. Another forcep was used to retreived the detached cup without incident anad the procedure was completed wiwth this second unit without complications. The patient experienced no sequelae as a result. Device labeled for single use. Patient medical status prior to event: unknown. 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. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1219544-1993-00047
• MDR Report Key: 7254
• Date Received: 1993-11-05
• Date of Report: 1993-10-14
• Date Facility Aware: 1993-10-07
• Report Date: 1993-10-14
• Date Reported to FDA: 1993-10-14
• Date Reported to Mfgr: 1993-10-14
• Date Added to Maude: 1994-01-13
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: UNKNOWN
• Health Professional: 3
• Initial Report to FDA: 3
• 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 G.I. BIOPSY FORCEP
• Generic Name: BIOSPY FORCEP
• Product Code: BWH
• Date Received: 1993-11-05
• Catalog Number: 1263
• Lot Number: 3062391A
• Device Expiration Date: 1994-06-01
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-SEP-93
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 6935
• Manufacturer: SYMBIOSIS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-11-05