WINER GRASPING FORCEPS, IN-LINE, RATCHET, 5MM, 33CM * 600-123

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-03-30 for WINER GRASPING FORCEPS, IN-LINE, RATCHET, 5MM, 33CM * 600-123 manufactured by Tontarra.

Event Text Entries

[441449] It was reported that half of the grasping forcep jaw borke off inside the patient during a procedure. The surgeon had to search for the broken piece. It took almost an hour to recover the broken piece. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2430952-2006-00013
• MDR Report Key: 694635
• Date Received: 2006-03-30
• Date of Report: 2006-03-29
• Date Facility Aware: 2006-03-01
• Report Date: 2006-03-29
• Date Reported to FDA: 2006-03-29
• Date Added to Maude: 2006-04-04
• 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: 3
• 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: WINER GRASPING FORCEPS, IN-LINE, RATCHET, 5MM, 33CM
• Generic Name: JARIT ENDOSCOPIC INSTRUMENTS
• Product Code: EMH
• Date Received: 2006-03-30
• Model Number: *
• Catalog Number: 600-123
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 683764
• Manufacturer: TONTARRA
• Manufacturer Address: * * GM
• Baseline Brand Name: WINER GRASPING FORCEPS, IN LINE RATCHET 5MM 33CM
• Baseline Generic Name: JARIT ENDOSCOPIC INSTRUMENTS
• Baseline Model No: *
• Baseline Catalog No: 600-123
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-03-30