SLIMLINE SEMI-RIGID BIOPSY FORCEPS GYB-5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2001-09-17 for SLIMLINE SEMI-RIGID BIOPSY FORCEPS GYB-5 manufactured by Circon Acmi.

Event Text Entries

[217216] Forceps cup broke in half.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1519132-2001-00071
• MDR Report Key: 352057
• Report Source: 06
• Date Received: 2001-09-17
• Date of Report: 2001-09-14
• Date Mfgr Received: 2001-08-17
• Date Added to Maude: 2001-09-20
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: MARY PICKARD
• Manufacturer Street: 300 STILLWATER AVE
• Manufacturer City: STAMFORD CT 06902
• Manufacturer Country: US
• Manufacturer Postal: 06902
• Manufacturer Phone: 2033288721
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SLIMLINE SEMI-RIGID BIOPSY FORCEPS
• Generic Name: BIOPSY FORCEPS
• Product Code: HFB
• Date Received: 2001-09-17
• Returned To Mfg: 2001-08-17
• Model Number: GYB-5
• Catalog Number: GYB-5
• Lot Number: NI
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 341343
• Manufacturer: CIRCON ACMI
• Manufacturer Address: 93 NORTH PLEASANT ST. NORWALK OH 448570409 US
• Baseline Brand Name: SEMI-RIGID BIOPSY FORCEPS
• Baseline Model No: GYB-5
• Baseline Catalog No: GYB-5
• Baseline ID: NA
• Baseline Device Family: FORCEPS
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0		2001-09-17