CONMED 134006

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-19 for CONMED 134006 manufactured by Conmed Corp..

Event Text Entries

[49253] During a laparotomy, a co hand control malleable abc handpiece was used with the argon beam coagulator. A spark was noted at the gap between the bendable wand & the handpiece, which burned the pt in two places. A tear was visualized in the black covering at the point the bendable wand attaches to the handpiece.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 78303
• MDR Report Key: 78303
• Date Received: 1997-03-19
• Date of Report: 1997-02-26
• Date of Event: 1997-02-20
• Date Facility Aware: 1997-02-20
• Report Date: 1997-02-28
• Date Added to Maude: 1997-03-27
• 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
• Reporter Occupation: RISK MANAGER
• 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: CONMED
• Generic Name: BEND-A-BEAM 6 IN. HAND CONTROL MALLEABLE ABC HANDPIECE
• Product Code: HQP
• Date Received: 1997-03-19
• Model Number: NA
• Catalog Number: 134006
• Lot Number: J86373A
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 77931
• Manufacturer: CONMED CORP.
• Manufacturer Address: 310 BROAD ST. UTICA NY 13501 US
• Baseline Brand Name: CONMED BEND-A-BEAM ABC HANDPIECE
• Baseline Generic Name: ABC HANDPIECE
• Baseline Model No: NA
• Baseline Catalog No: 134006
• Baseline ID: NA
• Baseline Device Family: ABC UNITS AND ACCESSORIES
• Baseline Shelf Life Contained: *
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K961505
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-03-19